[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Natera, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":376},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,61,88,126,174,199,231,264,285,328,354],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100609434","signatera-guided-cdk46-inhibitor-therapy-in-breast-cancer-100609434",false,"NCT07214532","Signatera-Guided CDK4\u002F6 Inhibitor Therapy in Breast Cancer","SIgnatera-Guided Initiation of Adjuvant CDK4\u002F6 Inhibitor in Intermediate Risk HR+ HER2- Breast Cancer","SIGNAL-ER 101","Inclusion Criteria:\n\n1. Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specific screening procedure.\n2. Patient is ≥ 18 years-old at the time of ICF signature.\n3. Patient is female with known menopausal status at the time of initiation of adjuvant endocrine therapy (ET), or male.\n4. Patient with histologically confirmed unilateral and unifocal primary invasive adenocarcinoma of the breast prior to initiating adjuvant chemotherapy, if indicated, or within 6 months of initiating adjuvant endocrine therapy if chemotherapy is not indicated. Patients who receive neoadjuvant endocrine therapy or chemotherapy are allowed to enroll.\n5. Patient has breast cancer that is positive for ER and\u002For PR according to the local laboratory as determined on the most recently analyzed tissue sample.\n6. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test (FISH, CISH, or SISH) or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (ISH) test is required to confirm the HER2-negative status.\n7. Patient has available archival tumor tissue from the diagnostic biopsy or surgical specimen, for submission to a central laboratory for Signatera testing (unless Signatera Genome clinical testing has already been performed).\n8. Patient after surgical resection where tumor was removed completely (i.e., negative microscopic margins on final pathology) and have Anatomic Stage II that is eligible for adjuvant CDK4\u002F6 inhibitors. The criteria to be eligible for adjuvant CDK4\u002F6 inhibitors include N1, or N0 with T3 or T2 with either G3, or G2 with Ki67 greater or equal to 20% or high genomic risk score.\n\n   Notes:\n   1. Patients who received neoadjuvant treatment must meet the criteria for stage, grade, Ki67 in any presurgical staging\u002Fsample and\u002For in the surgical specimen.\n   2. Categorization into the AJCC 8th edition Anatomic Stage Groups requires determination of the T, N and M categories. ALND can be omitted.\n9. Patient has no contraindication to adjuvant ET and is planned to be treated with ET for 5 years (since enrollment date) or more.\n10. Provider and patient must be agreeable to initiate CDK4\u002F6 inhibitors only upon ctDNA detection.\n11. Patient may have received up to 6 months of standard adjuvant ET at the time of enrollment and any amount of neoadjuvant endocrine therapy.\n12. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n13. Patient must not have a clinical contraindication to ribociclib or abemaciclib.\n14. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n15. Women of childbearing potential (CBP) must have a confirmed negative serum pregnancy test within 14 days prior to enrollment.\n16. Women of reproductive potential should be advised of the potential risk of CDK4\u002F6 inhibitors to a fetus, and use effective contraception during CDK 4\u002F6 inhibitor therapy.\n\nExclusion Criteria:\n\n1. Patient has had prior exposure to a CDK4\u002F6 inhibitor.\n2. Patient is concurrently using hormone replacement therapy.\n3. Patient with a known contraindication or hypersensitivity to ribociclib or abemaciclib as per the FDA indication label.\n4. Patients with a multicentric and\u002For multifocal and synchronous contralateral breast cancer are ineligible.\n5. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n6. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 5 years before ICF signature. Note: Patients with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to enrollment.\n7. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.) or limit life expectancy to ≤5 years.\n8. Patient participated in another interventional study and received treatment with an investigational product (or used an investigational device) within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.","ALL","18 Years",{"count":20,"type":21},725,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4\u002F6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as \"Signatera Genome\") in participants with intermediate-risk HR+\u002FHER2- early-stage breast cancer. Based on ctDNA test results, participants will either start CDK4\u002F6 inhibitor therapy in addition to hormone therapy or continue hormone therapy with ongoing ctDNA surveillance. This study will compare outcomes to historical controls from the NataLEE trial to determine whether ctDNA-guided timing maintains efficacy while reducing unnecessary treatment. Participants will be followed for up to 9 years with regular blood draws, hormone therapy, imaging as needed, and quality-of-life assessments.",[27,28,29],"Breast Neoplasms","Carcinoma, Ductal, Breast","Receptors, Estrogen (for ER-positive Requirement)",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47],"ctDNA","Circulating tumor DNA","Signatera","CDK4\u002F6 inhibitor","Ribociclib","Abemaciclib","Molecular residual disease","MRD","Biomarker-guided therapy","Adjuvant therapy","Hormone receptor positive","HER2 negative","Early breast cancer","Intermediate risk breast cancer","breast cancer","Endocrine therapy","Tumor-informed assay","RECRUITING","2026-08-11",{"date":51,"type":52},"2026-08-13","ACTUAL",{"date":54,"type":52},"2026-05-08",{"date":56,"type":21},"2037-12-30",{"name":58,"class":59},"Natera, Inc.","INDUSTRY",48,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100651669","sample-collection-for-ongoing-research-and-product-evaluation-study---non-muscle-invasive-bladder-cancer-score-nmibc-100651669","NCT07763197","Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)","SCORE-NMIBC","Inclusion Criteria:\n\n1. Patient is at least 18 years of age or older.\n2. Eastern Cooperative Oncology Group performance status ≤ 2.\n3. Patient has a suspected high risk non-muscle invasive bladder cancer.\n\n   Note: The AUA\u002FSUO risk stratification for primary non-muscle invasive bladder cancer will be used to determine high risk of tumor progression based on clinic and pathologic prognostic factors (Holzbeierlein et al., 2024):\n   1. High grade T1.\n   2. Any recurrent, High-grade TA.\n   3. High grade TA, \\>3 cm (or multifocal).\n   4. BCG failure in high grade patient.\n   5. Any variant histology.\\*\n\n      \\*e.g. Micropapillary, plasmacytoid, small cell\u002Fneuroendocrine, and sarcomatoid histologies (in pure or mixed form with associated urothelial carcinoma)\n   6. Any lymphovascular invasion.\n   7. Any high grade prostatic urethral invasion.\n4. Meet the following criteria:\n\n   a. Cohort A: i. Participant has high risk ≤ T1 bladder cancer and is eligible for intravesical therapy or cystectomy. ii. Participant has been treated with intravesical and\u002For systemic therapy for high risk ≤ T1 bladder cancer and is entering surveillance. b. Cohort B i. Participant has high risk ≤ T1 bladder cancer and undergoing primary treatment with cystectomy. ii. Patients undergoing cystectomy following recurrence or progression of high risk ≤ T1 bladder cancer and where ≤ T1 bladder cancer is confirmed on cystectomy surgical pathology.\n5. Willing and able to tolerate blood draws according to Natera standard process.\n6. Willing to provide urine collection samples.\n7. Able to consent to and provide residual tumor tissue for research.\n8. Willing and able to comply with the study requirements.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Prior history and treatment for any cancer (including muscle invasive bladder cancer) within the past year, or if they have any other active cancer, with the exception of participants who have undergone surgical removal of basal or squamous skin cancers, as well as those who have received NMIBC-directed therapy, including those undergoing cystectomy for primary NMIBC or after recurrence\u002Fprogression of NMIBC.\n3. Diagnosis of \\>T1 bladder cancer at time of enrollment.\n4. Tumor tissue unavailable and\u002For consists only of carcinoma in situ (CIS) disease.\n5. At time of enrollment, has undergone or plans to undergo any ctDNA or utDNA testing to assess MRD, with the exception of one-time comprehensive genomic profiling for therapeutic drug selection.\n6. History of bone marrow or organ transplant.\n7. Serious medical conditions that may adversely affect ability to participate in the study.",{"count":69,"type":21},400,"OBSERVATIONAL","The SCORE-NMIBC study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with non-muscle Invasive Bladder Cancer (NMIBC). Study participants will undergo research blood and urine collections, as well as tumor tissue collected as part of a standard-of-care procedure(s), for use in research. Collected samples and data will be analyzed to evaluate biomarkers associated with development and validation of cancer monitoring and detection assays (\"Natera cancer monitoring and detection test(s)\").",[73,74,75],"Non-Muscle Invasive Bladder Cancer","NMIBC","High-risk Non-Muscle Invasive Bladder Cancer",[73,74,77,78,79],"Cystectomy","High-grade T1 Bladder Cancer","High-grade Ta Bladder Cancer","2026-08-09",{"date":51,"type":52},{"date":83,"type":21},"2026-07-27",{"date":85,"type":21},"2032-07",{"name":58,"class":59},1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":97,"conditions":98,"keywords":109,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":87},"100650658","sample-collection-for-ongoing-research-and-product-evaluation-study---non-hodgkin-lymphoma-score-nhl-100650658","NCT07750886","Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL)","SCORE-NHL","Inclusion Criteria:\n\n1. Patient is at least 18 years of age or older.\n2. Eastern Cooperative Oncology Group performance status ≤ 2.\n3. Patients who are able to consent to and provide residual tumor tissue for research. Bone marrow specimens are excluded as acceptable tumor tissue.\n4. Patients with a new diagnosis of Stage I to IV aggressive non-Hodgkin lymphoma (NHL) including all aggressive large B-cell lymphoma (DLBCL, HGBCL, PMBCL), T-cell lymphoma (PTCL, ALCL), follicular lymphoma (FL) grade 3B, or transformed FL.\n5. Patients who are planning to receive six cycles of first-line therapy with an anthracycline-based chemotherapy regimen as per the standard of care.\n6. Radiographically measurable disease with at least one hypermetabolic lesion by Lugano classification on baseline FDG PET\u002FCT or FDG PET (radiographically measurable disease by CT with intravenous contrast is allowed if FDG-PET\u002FCT is not available).\n7. Able to tolerate blood draws according to Natera standard process.\n\nExclusion Criteria:\n\n1. Diagnosis of an indolent lymphoma that does not require immediate intervention, Hodgkin lymphoma, small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL). Other NHL diagnoses beyond DLBCL, aggressive TCLs, and grade 3B or transformed FL.\n2. Diagnosis of aggressive NHL that has a circulating, leukemic component, bone marrow or blood involvement.\n3. History of an allogeneic stem cell transplant or other organ transplant.\n4. Prior history and treatment for any cancer within the past year or another active cancer, with the exception of participants who have undergone surgical removal of skin squamous cell or basal cell cancers.\n5. Clinical ctDNA-MRD testing by any platform.\n6. Concurrent treatment that includes an investigational agent.",{"count":96,"type":21},200,"The SCORE-NHL study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with aggressive Stage I to IV non-Hodgkin Lymphoma (NHL). Study participants will undergo research blood collections of up to 60 mL as well as residual tissue collection, collected as part of a standard of care procedure, for use in research. Collected samples and data will be analyzed to evaluate biomarkers associated with development and validation of cancer monitoring and detection assays (\"Natera cancer monitoring and detection test(s)\").",[99,100,101,102,103,104,105,106,107,108],"Non-Hodgkin Lymphoma","T-Cell Lymphoma","Diffuse Large B-Cell Lymphoma","High-Grade B-Cell Lymphoma","Primary Mediastinal B-Cell Lymphoma","Peripheral T-Cell Lymphoma","Transformed Follicular Lymphoma","Follicular Lymphoma Grade 3B","Follicular Lymphoma","Anaplastic Large Cell Lymphoma",[99,100,110,103,104,108,105,111,107,112,113,114,102,115,116,117,118],"Diffuse Large B Cell Lymphoma","Follicular Lymphoma grade 3B","NHL","DLBCL","HGBCL","PMBCL","PTCL","FL","ALCL","2026-08-03",{"date":121,"type":52},"2026-08-06",{"date":83,"type":21},{"date":124,"type":21},"2032-04",{"name":58,"class":59},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":154,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100646600","a-multicenter-randomized-open-label-trial-evaluating-ctdna-guided-interruption-versus-standard-of-care-immune-checkpoint-inhibitor-ici-therapy-in-patients-with-advanced--metastatic-solid-tumors-100646600","NCT07689812","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced \u002F Metastatic Solid Tumors.","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Continuous Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced\u002FMetastatic Solid Tumors","SIGNAL-IO 301","Inclusion Criteria:\n\nGeneral inclusion criteria includes the following selection criteria to be eligible for inclusion in any aspect of the study. Eligibility will be assessed by the investigator:\n\n1. Signed Informed consent\n2. Age ≥ 18 years\n3. ECOG 0-2.\n4. Histologically confirmed advanced\u002Fmetastatic solid tumors including:\n\n   1. Melanoma: Unresectable recurrent, advanced, or metastatic\n   2. NSCLC: Advanced or metastatic\n   3. MSI-High\u002FdMMR CRC: Metastatic\n   4. RCC: Unresectable recurrent, advanced, or metastatic\n   5. Other: Metastatic solid tumors\n5. Received first line ICI monotherapy or dual-ICI therapy (e.g., PD-1\u002FCTLA-4 combination therapy) for a minimum of 12 months (maximum of 15 months) for NSCLC, RCC \\& other metastatic solid tumors, or for a minimum of 6 months (maximum of 9 months) for melanoma and MSI-High \u002FdMMR CRC. Exceptions permitted:\n\n   * For patients with NSCLC: First line platinum-based chemo-ICI regimens if on maintenance ICI +\u002F- pemetrexed.\n   * For patients with melanoma: nivolumab\u002Frelatlimab is permissible.\n6. Radiographic CR\u002FPR: Participants must have CR or PR at the last assessment performed within 6 weeks before randomization according to RECIST v1.1 using a diagnostic CT and\u002For MRI. Radiographic assessment must be confirmed by the BICR prior to randomization.\n7. Known ctDNA-negative with a tissue-informed assay\n\n   * ≥ 2 consecutive ctDNA-negative results at least 6 weeks apart; last test within 1 month of enrollment.\n   * Note: A confirmatory Signatera Genome negative test must be completed at enrollment if previous ctDNA testing performed for clinical care was done with a test other than Signatera Genome.\n8. Adequate organ function:\n\n   1. Hematology: ANC ≥1500\u002FμL; Platelets ≥100000\u002FμL;Hemoglobin ≥9.0g\u002FdL;\n   2. Renal: Serum Cr ≤1.5×ULN or calculated CrCl ≥60 mL\u002Fmin (using Cock-Gault formula);\n   3. Hepatic: Total bilirubin ≤1.5 ×ULN or, for participants with total bilirubin levels \\>1.5×ULN, direct bilirubin within normal limits; AST (SGOT) and ALT (SGPT) ≤2.5×ULN;\n   4. Coagulation: INR or PT, activated partial thromboplastin time (APTT) ≤1.5×ULN Note: Laboratory assessments performed as part of standard of care evaluations during immunotherapy treatment administration may be used to satisfy these eligibility criteria, provided they are obtained within 28 days of enrollment.\n9. Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v6 from AE(s) related to any prior treatments unless AE(s) are deemed clinically non-significant (e.g., Grade 2 alopecia) by the Investigator and\u002For stable on supportive therapy.\n10. No prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since completion of definitive therapy\n11. Participants must be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures\n12. Women of child-bearing potential (WOCBP) and male participants partnering with WOCBP must agree to use highly effective contraception during the treatment phase and at least 180 days post last dose\n13. Patients must be willing to discontinue clinically-directed ctDNA testing for treatment response monitoring during the period of clinical trial testing as dictated by the protocol.\n\nExclusion Criteria\n\nPatients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:\n\n1. Available alternate treatment options with curative intent, e.g. surgery and \u002F or RT and \u002F or Chemotherapy.\n2. Symptomatic or progressing CNS metastases; or presence of leptomeningeal disease.\n3. Patient has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. (Note: Participants with splenectomy are allowed.) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.\n4. Patient is receiving systemic steroid therapy ≤3 days prior to enrollment or receiving any other form of immunosuppressive medication with the exception of daily steroid replacement therapy. Note: Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.\n5. Had allogeneic tissue\u002Fsolid organ transplantation.\n6. Interstitial lung disease or history of pneumonitis that has required oral or IV steroids. Note: Patients with lymphangitic carcinomatosis secondary to NSCLC can be considered as eligible.\n7. Has received or will receive a live vaccine within 30 days prior to enrollment (seasonal flu vaccines that do not contain live vaccine are permitted).\n8. Active infection requiring intravenous systemic therapy.\n9. Known history of human immunodeficiency virus (HIV).\n10. Known active Hepatitis B or C.\n11. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n12. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of enrollment.\n13. Use of any commercial ctDNA or liquid biopsy monitoring outside of the study protocol during the treatment monitoring phase within the protocol.",{"count":135,"type":21},920,[24],"This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI therapy in patients with histologically confirmed advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), melanoma, microsatellite instability-high (MSI-High)\u002FDeficient Mismatch Repair (dMMR) colorectal cancer (CRC), renal cell carcinoma (RCC) and other solid tumors. This study will be conducted in up to 100 sites.",[139,140,141,142,143,144,145,146,147,148,149,150,151,152,153],"NSCLC (Advanced Non-small Cell Lung Cancer)","NSCLC (Non-small Cell Lung Cancer)","NSCLC (Non-small Cell Lung Carcinoma)","NSCLC","Melanoma (Skin Cancer)","Melanoma (Skin) Stage IV","CRC","MSI High Colorectal Cancer","DMMR Colorectal Cancer","RCC, Renal Cell Cancer","RCC","Solid Tumors","Metastatic Solid Tumors","Advanced Solid Tumors","Advanced Solid Tumors Cancer",[31,32,155,156,157,142,158,159,160,161,145,162,149,163,33,37,38,39,40,47,164],"Immune checkpoint inhibitor","ICI","Non-small cell lung cancer","Melanoma","Microsatellite Instability-High\u002Fdeficient Mismatch Repair","MSI-High\u002FdMMR","Colorectal Cancer","Renal cell carcinoma","Metastatic solid tumors","Advanced solid tumor","NOT_YET_RECRUITING","2026-07-31",{"date":168,"type":52},"2026-08-04",{"date":170,"type":21},"2026-12",{"date":172,"type":21},"2034-03",{"name":58,"class":59},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":4},"100648382","immunosuppression-optimization-using-the-prospera-assay-in-kidney-transplant-recipients-impakt-100648382","NCT07718633","Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)","Immunosuppressant optiMization Using the Prospera Assay in Kidney Transplant (IMPAKT) Randomized Controlled Trial","IMPAKT","Inclusion Criteria:\n\n* Subjects received a kidney transplant in the prior 3 months.\n* Subjects receiving maintenance therapy consisting of tacrolimus, mycophenolate sodium or mycophenolate mofetil, and optionally corticosteroids, at the time of enrollment.\n* Subjects received induction therapy comprising IL2 receptor antagonist or thymoglobulin, or received no induction therapy.\n* 18 years of age or older at time of signing informed consent.\n* Able to read, understand and provide written informed consent, and willing and able to comply with the study requirements. If the subject is unable to sign the informed consent, a legally authorized representative (LAR) can consent on behalf of the subject.\n* Subjects are at the site standard-of-care MPA dosage\n\nExclusion Criteria:\n\n* Concurrent multiple solid organ or tissue transplants.\n* History of a previous organ transplant (aside from present kidney transplant), or cellular transplant.\n* DSA Positive according to local protocol, including either pre-transplant DSA positivity and de novo DSA positivity.\n* Any prior dd-cfDNA results ≥1.0% or ≥78cp\u002FmL after 28 days post-transplant.\n* ABO Incompatible donor.\n* A serious medical condition that may adversely affect ability to participate in the study (e.g, current diagnosis of cancer).\n* Pregnancy.\n* Received any induction therapy other than IL2 receptor antagonist or thymoglobulin.\n* Receiving any maintenance immunosuppression other than tacrolimus, mycophenolate sodium or mycophenolate mofetil, and prednisone.\n* Currently undergoing regular dialysis.\n* Considered high-risk at the time of enrollment, as per the treating physician.\n* Planned or ongoing use of other commercially available or investigational dd-cfDNA or blood-based gene expression profile assays for rejection surveillance, through randomization.",{"count":183,"type":21},750,[24],"IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.",[187,188],"Kidney Transplant","Immunosuppresion",[187,190],"Immunosuppression","2026-07-17",{"date":193,"type":52},"2026-07-22",{"date":195,"type":21},"2026-07",{"date":197,"type":21},"2031-07",{"name":58,"class":59},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":207,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100619035","signatera-assessment-in-early-stage-endometrial-cancer-100619035","NCT07339384","Signatera Assessment in Early-Stage Endometrial Cancer","Circulating Tumor DNA Assessment in Early-Stage Endometrial Cancer (SIGNAL-EMC 101)","SIGNAL-EMC 101","Inclusion Criteria:\n\nGeneral inclusion criteria includes the following selection criteria to be eligible for inclusion in any aspect of the study. Eligibility will be assessed by the investigator:\n\n1\\. Signed and dated informed consent form (ICF) obtained prior to any trial-specific enrollment procedure.\n\n2\\. Patient is ≥ 18 years-old at the time of ICF signature. 3. Able to submit sufficient residual tissue obtained per standard of care procedures.\n\nHIR patients must meet all the following selection criteria to be eligible for the randomization cohort in the study. Eligibility will be assessed by the investigator:\n\n1. FIGO 2009 Stage I after hysterectomy and lymph node assessment by bilateral pelvic lymphadenectomy or SLND\n\n   1. If para-aortic lymph nodes are not pathologically assessed, documentation of surgical assessment or imaging is recommended.\n2. Stage I patients with endometrioid histology:\n\n   1. Age 70 years or older with one uterine risk factor,\n   2. Age 50-69 years with two risk factors,\n   3. Age 18 - 49 years with three risk factors.\n\nUterine risk factors include:\n\n* Grade 2 or 3 tumor.\n* Outer half depth of invasion.\n* Lymphovascular invasion. Note: peritoneal cytology must be negative if performed.\n\nPatients must meet all the following selection criteria to be eligible for the observation arms of the study. Eligibility will be assessed by the investigator following hysterectomy and lymph node assessment by bilateral pelvic and para-aortic lymphadenectomy or SLND:\n\n1\\. High risk cohort\n\na. FIGO 2009 Stage I with high risk histology i. Defined as serous, clear cell, carcinosarcoma, or mixed histology.\n\n1. Negative peritoneal cytology, where performed (recommended)\n2. If para-aortic lymph nodes are not pathologically assessed, imaging is required b. FIGO 2009 Stage II Endometrioid\n\n2\\. Low risk cohort\n\na. FIGO 2009 Stage I patients at low risk of recurrence i. Endometriod histology ii. Absent uterine risk factors, or present but insufficient to meet HIR criteria\n\nExclusion Criteria:\n\nPatients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:\n\n1. Undifferentiated or dedifferentiated histology\n2. Uterine sarcoma\n3. Prior pelvic radiation therapy\n4. Positive pelvic washings\n5. Pelvic lymph node assessment was not performed\n6. Isolated Tumor Cells (ITC) identified in the lymph node(s)\n7. Prior therapy for endometrial cancer (including hormonal therapy, chemotherapy, targeted therapy, immunotherapy)\n\n   a. Contraceptives or other hormonal management for endometrial intraepithelial hyperplasia is allowed\n8. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years.\n\n   a. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n9. Patients with a history of serious comorbid illness or uncontrolled illnesses that would preclude protocol therapy.\n10. Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment.\n11. Previous diagnosis of Crohn's disease or ulcerative colitis.\n12. Patient is currently receiving, or plans to receive, commercial ctDNA\u002FMRD assay for disease monitoring, excluding Signatera. Patients must agree to forego testing with assays other than Signatera Genome upon enrollment until end of study.","FEMALE",{"count":209,"type":21},1010,[24],"The goal of this clinical trial is to assess if circulating tumor DNA can guide adjuvant selection in high-intermediate risk early-stage endometrial cancer. The main question it aims to answer is:\n\n• To evaluate if 3-year recurrence-free survival among women with Stage I, high-intermediate risk endometrial cancer who are ctDNA negative after receiving ctDNA-guided observation is non-inferior to adjuvant vaginal brachytherapy (an internal radiation therapy) Researchers will compare high-risk intermediate ctDNA negative participants who are observed to those who receive vaginal brachytherapy to see if they have similar outcomes.\n\nParticipants will be asked to:\n\n* Receive serial ctDNA testing\n* Visit their study doctor per their standard of care visits about every 3 months for 2 years\n* Answer a questionnaire about their well-being",[213],"Endometrial Cancer",[31,213,215,33,216,38,217,218,219,220,221,47],"circulating tumor","Molecular Residual Disease","biomarker-guided therapy","Vaginal Brachytherapy","VBT","High-Intermediate Risk Endometrial Cancer","Adjuvant Therapy","2026-06-15",{"date":224,"type":52},"2026-06-17",{"date":226,"type":21},"2026-10",{"date":228,"type":21},"2034-10",{"name":58,"class":59},12,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":4},"100636451","signatera-guided-de-escalation-of-adjuvant-therapy-in-resectable-stage-ii-iva-gastricgastric-esophageal-cancer-100636451","NCT07565857","Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric\u002FGastric-Esophageal Cancer","SIGNAL GEC-101: Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric\u002FGastric-Esophageal Cancer","SIGNAL GEC-101","Inclusion Criteria:\n\n1. Signed and dated informed consent form (ICF) obtained prior to any trial-specific enrollment procedure.\n2. Age is ≥ 18 years-old at the time of ICF signature.\n3. Able to submit adequate archival tumor tissue (eg, 6 to 10 unstained slides at 10 microns (μm) each or 12-19 unstained slides at 5-microns (μm) plus one hematoxylin and eosin slide (see study lab manual) obtained per standard of care procedures for submission to a central laboratory for Signatera testing OR prior commercial Signatera Genome test results.\n4. Histologically confirmed adenocarcinoma of the stomach, esophagus and\u002For gastroesophageal junction (GEJ), resectable clinical Stage II-IVa per AJCC 9th edition.\n5. Completion of full or modified course (based on Dosing and Modification Guidelines) of neoadjuvant D-FLOT therapy (ie, two 4-week cycles of durvalumab, four 2-week cycles of FLOT) .\n6. Has undergone complete surgical resection of the gastric\u002FGEJ tumor with pathologically confirmed negative margins (R0 resection).\n7. Eligible to receive adjuvant D-FLOT treatment within 12 weeks postoperative per standard of care (SOC) as assessed by the treating clinician.\n8. Known statuses pertaining to randomization stratification factors:\n\n   1. Post neoadjuvant, post-operative (yp) lymph node status and tumor staging (ypT1-3, N0 vs T4 or N+)\n   2. Combined Positive Score ( ≥ 1 vs \\\u003C1)Tumor PD-L1 status confirmed by immunohistochemistry\u002FCPS score.\n   3. Post neoadjuvant, post-operative major pathological response (MPR): Yes\u002FNo\n9. ECOG performance status 0-1.\n10. No evidence of disease by radiographic imaging.\n11. Must be willing to and able to comply with adjuvant treatment plans based on ctDNA results and other trial-mandated procedures.\n12. Women of child bearing potential must have a confirmed negative pregnancy test within 14 days of enrollment per institutional standards.\n\nExclusion Criteria:\n\n1. Histologic presence of adenosquamous cell carcinoma, squamous cell carcinoma, gastrointestinal stromal tumor, or neuroendocrine tumors.\n2. Radiographic evidence of unresectable metastatic disease (ie, IVb).\n3. Presence of peritoneal dissemination.\n4. Any prior therapy (eg, radiation, chemoradiation, chemotherapy) for gastric or gastroesophageal cancer other than neoadjuvant D-FLOT and R0 curative intent surgery.\n5. Known contradiction or hypersensitivity to durvalumab per the prescribing information; known contraindication or hypersensitivity to Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel or any of the drug excipients.\n6. Known history of active primary immunodeficiency (eg, HIV), other contraindications of immunotherapy or receiving immunosuppressive medication per approved label.\n7. Female participants who are pregnant or breastfeeding.\n8. Concurrent enrollment in another clinical trial unless the study is observational, non-interventional.\n9. Use of any commercial ctDNA or liquid biopsy monitoring outside of the study protocol during the primary 36-month monitoring period.\n10. Concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 5 years before ICF signature. Note: Participants with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to enrollment.\n11. Any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical trial or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.)",{"count":240,"type":21},1000,[24],"The goal of this clinical trial is to assess if circulating tumor DNA, as assessed by Signatera tumor-informed MRD assay, can guide de-escalation of adjuvant therapy in patients with resectable Stage II-IVa Gastric\u002FGastric-Esophageal Cancer. The main question it aims to answer is:\n\n• To demonstrate if 2-year disease-free survival (DFS) among participants with resectable clinical Stage II-IVa gastric\u002Fgastro-esophageal cancer who received neoadjuvant D-FLOT and are ctDNA negative after curative intent R0 surgery receiving adjuvant durvalumab monotherapy is non-inferior to standard of care D-FLOT.\n\nResearchers will compare post-operative ctDNA negative participants who are receiving adjuvant durvalumab monotherapy to those who receive standard of care (D-FLOT) to see if they have similar outcomes.\n\nParticipants will be asked to:\n\n* Receive serial ctDNA testing\n* Visit their study doctor per their standard of care visits about every 3 months for first 2 years and then every 6 months for an additional 3 years\n* Answer 5 questionnaires about their well-being",[244],"Gastric-Esophageal Cancer",[31,32,244,33,37,38,39,246,247,248,249,250,251,40,47,252,253,254,255],"Durvalumab","Fluorouracil","Leucovorin","Oxaliplatin","Docetaxel","D-FLOT","Gastric Cancer","Esophageal Cancer","Gastric adenocarcinoma","ctDNA-guided","2026-05-01",{"date":258,"type":52},"2026-05-04",{"date":260,"type":21},"2026-09",{"date":262,"type":21},"2034-09",{"name":58,"class":59},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},"100578252","expanding-prenatal-cell-free-dna-screening-across-monogenic-disorders-expand-100578252","NCT06808880","EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND)","EXPAND","Inclusion Criteria:\n\n1. Age 18 or older at the time of informed consent\n2. Maternal participant: Pregnant and blood draw at ≥ 9 weeks gestational age (GA)\n3. Maternal participant is positive for a single-gene disorder and\u002For there are prenatal ultrasound findings suggestive for a fetal single-gene disorder, including but not limited to the genes listed in the primary and secondary objectives\n4. Meet the criteria for one of the following:\n\n   * Both maternal and reproductive partner (paternal) status are positive for the same single-gene disorder OR\n   * A commercially available single-gene NIPT has been performed as part of clinical care and is reported as increased risk for an affected fetus\u002Ffetuses OR Maternal status is positive for one or more single-gene disorders and reproductive partner status is unknown OR\n   * Prenatal ultrasound findings are suggestive of a fetal single-gene disorder (autosomal dominant, autosomal recessive, or X-linked condition) and enrollment is approved by the medical monitor.\n5. Willing to permit release of neonatal health information and the performance of a newborn cheek swab within 6 months following delivery\n6. Willing to sign informed consent and comply with study procedures\n\nExclusion Criteria:\n\n1. Reproductive partner found to not be positive for the same autosomal recessive genetic disorder as the pregnant maternal carrier, or vice versa\n2. Surrogate gestation or egg donor pregnancy\n3. Negative preimplantation genetic testing for the single-gene disorder identified in one or both parents",{"count":272,"type":21},4000,"The purpose of this research is to develop and validate a single gene Non-Invasive Prenatal Test. The development of this investigational single-gene noninvasive prenatal testing (sgNIPT) for conditions such as cystic fibrosis (CF), spinal muscular atrophy (SMA), Sickle cell disease, alpha thalassemia (a-thalassemia) and beta thalassemia (b-thalassemia) could provide information about the possibility that a child will be born with a serious health condition, in some cases in the absence of reproductive partner screening.\n\nIn order to develop a test for this purpose, investigators will collect blood samples and medical information from pregnant women who have pregnancies at higher risk for single gene disorders, such as those who are carriers for these conditions or affected by these conditions themselves, medical data from their reproductive partners in some cases, and either genetic testing results or a cheek swab sample from the newborn(s).",[275],"Single Gene NIPT",[277],"single gene NIPT",{"date":258,"type":52},{"date":280,"type":52},"2024-01-25",{"date":282,"type":21},"2027-12",{"name":58,"class":59},18,{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":295,"conditions":296,"keywords":308,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":87},"100617394","sample-collection-for-ongoing-research-and-product-evaluation-study-100617394","NCT07318051","Sample Collection for Ongoing Research and Product Evaluation Study","Sample Collection for Ongoing Research and Product Evaluation (SCORE) Study","SCORE","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Any patient that has an untreated primary solid malignancy within the following cohorts:\n\n   1. Breast cancer\n   2. Lung cancer\n   3. Muscle invasive bladder cancer\n   4. Rectal cancer\n   5. Pancreatic cancer\n   6. Ovarian cancer\n   7. Gastroesophageal cancer\n   8. Prostate cancer\n   9. Melanoma\n   10. Hepatic\u002Fliver cancer\n   11. Uterine\u002Fendometrial cancer\n   12. Head and neck Cancer\n3. The participant has a suspected primary malignancy of pancreatic, endometrial, bladder, or ovarian cancer based on imaging.\n4. Eastern Cooperative Oncology Group performance status ≤ 2.\n5. Able to tolerate venipuncture for research blood draw(s).\n6. Consent to provide residual tumor tissue for research.\n7. Willing and able to comply with the study requirements.\n8. Signed informed consent(s) must be obtained prior to participation in the study.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of participants who have undergone surgical removal of skin squamous cell or basal cell cancers.\n3. Has initiated postoperative systemic treatment.\n4. At time of enrollment, has undergone or plans to undergo any ctDNA testing to assess molecular residual disease, with the exception of comprehensive genomic profiling for therapeutic selection.\n5. History of bone marrow or organ transplant.\n6. Serious medical conditions that may adversely affect ability to participate in the study.",{"count":294,"type":21},9600,"The SCORE study is a prospective, multi-site clinical trial designed to collect blood and tissue samples, along with relevant clinical data, from participants diagnosed with various solid tumors. The collected specimens and information will be used to evaluate the clinical performance of Natera's molecular residual disease (MRD) testing across multiple cancer types. The study aims to assess the ability of Natera's assays to detect circulating tumor DNA (ctDNA) as a marker for disease recurrence and treatment response.",[297,298,299,300,301,302,303,304,158,305,306,307],"Breast Cancer","Lung Cancer","Muscle Invasive Bladder Cancer","Rectal Cancer","Pancreatic Cancer","Ovarian Cancer","Gastroesophageal Cancer","Prostate Cancer","Head and Neck Cancer","Uterine Cancer","Liver Cancer",[309,310,311,312,313,314,315,316,158,317,318,319],"Breast cancer","Lung cancer","Muscle invasive bladder cancer","Rectal cancer","Pancreatic cancer","Ovarian cancer","Gastroesophageal cancer","Prostate cancer","Head and Neck cancer","Uterine cancer","Liver cancer","2026-01-13",{"date":322,"type":52},"2026-01-15",{"date":324,"type":52},"2025-07-21",{"date":326,"type":21},"2035-01",{"name":58,"class":59},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":335,"sex":17,"minAge":336,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":87},"100596524","evaluation-of-the-natera-colorectal-cancer-screening-test-in-an-average-risk-population-find-crc-100596524","NCT07046585","Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)","FIND-CRC","Inclusion Criteria:\n\n1. Signed informed consent.\n2. 40 years of age or older at the time of consent.\n3. Planning or intending to undergo a standard of care colonoscopy.\n4. Able to tolerate venipuncture for research draw(s).\n5. Able and willing to provide blood samples within the 120 days prior to a standard-of-care pre-bowel preparation procedure and colonoscopy procedure.\n6. Willing and able to comply with the study visit schedule and study requirements.\n\nExclusion Criteria:\n\n1. Any prior history of any kind of malignancy (exception: participants who have undergone surgical removal of skin squamous cell or basal cell cancers may be enrolled, provided the procedure was completed at least 12 months prior to consent for the study).\n2. Had a complete colonoscopy with adequate bowel preparation in the previous nine (9) years.\n3. Undergoing diagnostic colonoscopy for the investigation of symptoms.\n4. Up to date with colorectal cancer screening from any non-invasive test.\n5. Precancerous findings on most recent colonoscopy.\n6. Had a prior colorectal resection for any reason other than sigmoid diverticular disease.\n7. Known personal history of any of the following high-risk conditions:\n\n7a. Inflammatory bowel disease. 7b. Known hereditary condition that would increase risk of colorectal cancer (example Lynch Syndrome).",true,"40 Years",{"count":338,"type":21},25000,"The FIND-CRC study is a prospective collection of samples and data from participants who are at average risk of developing colorectal cancer (CRC). Collected samples and data will be analyzed to evaluate the clinical performance of the Natera CRC Screening Test.",[341],"Colo-rectal Cancer",[343,344,345],"colorectal cancer","colon cancer","early cancer detection","2025-12-11",{"date":348,"type":52},"2025-12-12",{"date":350,"type":52},"2025-05-30",{"date":352,"type":21},"2033-09-30",{"name":58,"class":59},{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":335,"sex":17,"minAge":336,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":87},"100563781","prospective-collection-of-samples-to-enable-the-development-of-natera-screening-assay-for-early-cancer-detection-100563781","NCT06620627","Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection","Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection (PROCEED-CRC)","PROCEED-CRC","Inclusion Criteria:\n\n1. 40 years of age or older at time of consent.\n2. Planning or intending to undergo asymptomatic screening colonoscopy.\n3. Able to tolerate venipuncture for research draw(s).\n4. Able and willing to provide blood samples within the 120 days prior to a colonoscopy procedure.\n5. Willing and able to comply with the study visit schedule and study requirements.\n6. Signed informed consent(s) must be obtained prior to participation in the study\n\nExclusion Criteria:\n\n1. Any prior history of any kind of malignancy (exception: participants who have undergone surgical removal of skin squamous cell or basal cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)\n2. Had a complete colonoscopy with adequate bowel preparation in the previous nine (9) years.\n3. Undergoing diagnostic colonoscopy for investigation of symptoms such as unexplained and long-lasting diarrhea, overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)\n4. Undergone colorectal cancer screening within the associated recommended intervals\n\n   1. FOBT\u002FFIT within the previous 12 months\n   2. FIT-DNA test within the previous 36 months\n   3. Blood-based CRC screening test within the previous 36 months\n   4. Computed tomography colonography CTC within the previous 5 years\n   5. Flexible sigmoidoscopy within the previous 5 years\n5. Precancerous findings on most recent colonoscopy. This does not include benign, and\u002For hyperplastic polyps of any size (Note: Tissue biopsies that result in no histopathology findings are acceptable)\n6. Had a prior colorectal resection for any reason other than sigmoid diverticular disease\n7. Diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:\n\n   1. Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohns disease\n   2. Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP)\n   3. Hereditary non-polyposis colorectal cancer syndrome (also referred to as HNPCC or Lynch Syndrome)\n   4. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardners Syndrome, Turcots (or Crails) Syndrome, Cowdens Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis",{"count":363,"type":21},5000,"The PROCEED-CRC study will prospectively collect blood samples from participants who are at average risk of colorectal cancer (CRC). Samples will be used for research use and the development of a blood-based CRC screening test.",[366],"Colorectal Cancer Screening",[343,344],"2025-01-28",{"date":370,"type":52},"2025-01-29",{"date":372,"type":52},"2024-01-26",{"date":374,"type":21},"2025-10-31",{"name":58,"class":59},""]