[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658699":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":43,"studyPopulation":44,"armGroups":45,"interventions":39,"overallOfficials":49,"centralContacts":53,"locations":39,"responsibleParty":62,"collaborators":39,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":39,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":39,"enrollmentInfo":74,"targetDuration":39,"studyType":77,"phases":39,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":87,"whyStopped":39,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":39},{"fullName":5,"class":6},"Fox Chase Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Participants With ctDNA Detection at Least Three Months Before Clinically Confirmed Recurrence","Proportion of evaluable participants with documented lung cancer recurrence within 36 months after surgery who have a positive circulating tumor DNA (ctDNA) result at least three months before clinically confirmed recurrence. Recurrence is determined using standard-of-care imaging. The primary analysis includes participants with at least three months of follow-up and at least one evaluable ctDNA result obtained at or after the four-to-six-week postoperative assessment.","Up to 36 months after surgery.",[14,18,22,26,29,32,35],{"measure":15,"description":16,"timeFrame":17},"Recurrence-Free Survival by Postoperative ctDNA Status","Recurrence-free survival is measured from the ctDNA assessment performed four to six weeks after surgery to the first documented recurrence or death from any cause, whichever occurs first. Outcomes will be compared between participants with positive and negative ctDNA results at this postoperative landmark. Participants without an event will be censored at their last disease assessment.","From the four-to-six-week postoperative ctDNA assessment through up to five years after surgery.",{"measure":19,"description":20,"timeFrame":21},"Proportion of Participants With Negative ctDNA Results at Treatment Entry","Proportion of participants with a negative ctDNA result at entry into treatment. Treatment entry is defined as Cycle 1, Day 1 of neoadjuvant therapy for participants receiving neoadjuvant treatment, or the date of surgery for participants proceeding directly to surgical resection.","At treatment entry: Cycle 1, Day 1 of neoadjuvant therapy or the date of surgery.",{"measure":23,"description":24,"timeFrame":25},"Sensitivity of Postoperative ctDNA for Predicting Three-Year Recurrence","Proportion of participants who experience clinically confirmed recurrence within three years after surgery who have a positive ctDNA result at the four-to-six-week postoperative landmark assessment. The estimate will be reported with a 95% confidence interval.","ctDNA assessed four to six weeks after surgery; recurrence assessed through 36 months after surgery.",{"measure":27,"description":28,"timeFrame":25},"Specificity of Postoperative ctDNA for Predicting Three-Year Recurrence","Proportion of participants who do not experience clinically confirmed recurrence within three years after surgery who have a negative ctDNA result at the four-to-six-week postoperative landmark assessment. The estimate will be reported with a 95% confidence interval.",{"measure":30,"description":31,"timeFrame":25},"Positive Predictive Value of Postoperative ctDNA for Three-Year Recurrence","Proportion of participants with a positive ctDNA result at the four-to-six-week postoperative landmark assessment who experience clinically confirmed recurrence within three years after surgery. The estimate will be reported with a 95% confidence interval.",{"measure":33,"description":34,"timeFrame":25},"Negative Predictive Value of Postoperative ctDNA for Three-Year Recurrence","Proportion of participants with a negative ctDNA result at the four-to-six-week postoperative landmark assessment who do not experience clinically confirmed recurrence within three years after surgery. The estimate will be reported with a 95% confidence interval.",{"measure":36,"description":37,"timeFrame":38},"Time From First Positive ctDNA Result to Clinically Confirmed Recurrence","Time interval, measured in months, between the first positive ctDNA result and clinically confirmed recurrence among participants with both events. The interval will be summarized using descriptive statistics. The number and proportion of participants with positive ctDNA results without subsequent recurrence, and those with recurrence without a positive ctDNA result, will also be reported.","Through up to five years after surgery.",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":42,"maskingInfo":39},"COHORT","PROSPECTIVE","This prospective, single-center observational cohort study will evaluate the clinical validity of a blood-based circulating tumor DNA (ctDNA) assay for detecting molecular residual disease (MRD) and predicting recurrence in patients with surgically resectable stage IB-IIIA non-small cell lung cancer (NSCLC), as defined by the American Joint Committee on Cancer (AJCC) 9th edition. Approximately 200 treatment-naïve adults who are considered surgical candidates by their treating physicians will be enrolled at Fox Chase Cancer Center over approximately two years.\n\nParticipants will receive standard-of-care treatment according to multidisciplinary tumor board recommendations and the treating physician's clinical judgment. Treatment pathways may include surgery followed by adjuvant therapy, neoadjuvant chemoimmunotherapy followed by surgery and adjuvant therapy, or neoadjuvant therapy followed by surgery and observation. The protocol does not assign anticancer treatment or specify the selection of therapeutic agents.\n\nTumor tissue and peripheral blood will be collected for MRD assessment. Tumor tissue will preferably be obtained before neoadjuvant treatment; surgical tissue may be used when a pretreatment specimen is unavailable or when participants proceed directly to surgery. Blood samples for ctDNA analysis will be collected at baseline and at protocol-specified treatment time points. A postoperative blood sample obtained four to six weeks after surgery will establish the landmark MRD assessment. Additional samples will be collected during and after adjuvant treatment, as applicable. During surveillance, MRD blood samples will be collected every three months for the first three years and every six months thereafter, for up to five years.\n\nClinical disease assessments will use standard-of-care computed tomography (CT) scans, radiology reports, and the treating physician's clinical assessment. Participants will be followed for up to five years after surgery or until radiographically confirmed disease progression, subject to protocol discontinuation criteria. Participants who initiate neoadjuvant therapy but do not undergo surgery will remain in follow-up, with blood collection continuing when feasible. Their available data will contribute to exploratory analyses, but they will not be evaluable for analyses requiring surgical pathology or the postoperative landmark assessment.\n\nThe primary objective is to determine the proportion of evaluable participants with documented recurrence in whom ctDNA predicts recurrence at least three months before clinical confirmation. The primary analysis will evaluate recurrence within 36 months after surgery. Secondary objectives include assessing the association between postoperative landmark ctDNA status and recurrence-free survival; determining the proportion of participants with negative ctDNA results at treatment entry; evaluating the sensitivity, specificity, positive predictive value, and negative predictive value of landmark ctDNA results for three-year recurrence; and measuring the interval between the first positive ctDNA result and clinically confirmed recurrence. Recurrence-free survival is defined as the time from the four-to-six-week postoperative ctDNA measurement to the first documented recurrence or death from any cause.\n\nExploratory analyses will examine longitudinal ctDNA patterns and associations with treatment pathways, clinicopathologic characteristics, genomic alterations, and recurrence. In the first 50 participants receiving neoadjuvant therapy, additional blood, surgical tumor or tumor-bed tissue, lymph node tissue, and stool samples will support correlative studies. These studies will evaluate immune cell profiles, T-cell clonotype dynamics, and gut microbiome characteristics in relation to pathologic response, MRD status, and disease recurrence.","Adults aged 18 years or older with treatment-naïve, histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer (AJCC 9th edition) who are considered candidates for surgical resection by their treating physicians. Approximately 200 participants will be enrolled at Fox Chase Cancer Center. Participants will receive standard-of-care treatment, which may include neoadjuvant therapy, surgery, and adjuvant therapy, as clinically indicated. Enrollment includes surgical candidates regardless of whether neoadjuvant therapy is planned.",[46],{"label":47,"type":39,"description":48,"interventionNames":39},"Patients With Surgically Resectable Stage IB-IIIA NSCLC","Adults with treatment-naïve, histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer (AJCC 9th edition) who are considered surgical candidates by their treating physicians. Participants receive standard-of-care treatment, which may include neoadjuvant therapy, surgery, and adjuvant therapy, as clinically indicated. Serial blood samples and tumor tissue are collected for circulating tumor DNA and molecular residual disease analyses, with follow-up for cancer recurrence for up to five years after surgery. The first 50 participants receiving neoadjuvant therapy undergo additional blood, tissue, and stool collection for correlative studies.",[50],{"name":51,"affiliation":5,"role":52},"Hossein Borghaei, DO","PRINCIPAL_INVESTIGATOR",[54,58],{"name":51,"role":55,"phone":56,"phoneExt":39,"email":57},"CONTACT","215-728-4300","hossein.borghaei@fccc.edu",{"name":59,"role":55,"phone":60,"phoneExt":39,"email":61},"Henkel Valentine, PhD","267-882-0820","protocoldev@fccc.edu",{"type":63,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100658699","blood-testing-to-detect-cancer-recurrence-in-patients-with-early-stage-non-small-cell-lung-cancer-100658699",false,"NCT07854769","Blood Testing to Detect Cancer Recurrence in Patients With Early-Stage Non-Small Cell Lung Cancer","Detection of Molecular Residual Disease in Early-Stage Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed stage 1B-3A (AJCC 9th edition) non-small cell lung carcinoma regardless of histology.\n* Patients must be treatment-naïve.\n* Patients must be deemed to be surgical candidates as assessed by their treating physician.\n* Age ≥ 18 years.\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n* Must be willing and able to provide a core tumor biopsy.\n\n  1. A core tumor biopsy meeting minimum preanalytical requirements is necessary for MRD assay evaluation. The preference is for a sample prior to start of neoadjuvant treatment as roughly 20% of patients will have a complete response and won't have any tumor in the surgical sample. However, if not possible, then sample could come after surgery.\n  2. Patients who go directly to surgery could submit tumor samples after surgery.\n\nExclusion Criteria:\n\n* Patients with tumors are positive for EGFR exon 19 deletion or L858R mutation or ALK or ROS1 gene fusions are excluded.\n* Patients who at the discretion of investigators are not suitable for participation.\n* Patients must not be currently receiving any other investigational agents or immunomodulatory agents with the exception of drugs used for treatment of rheumatoid arthritis or psoriasis\n* Patients with contraindication to chemotherapy or immunotherapy or refuse these treatments.\n* Patients who are unable\u002Frefuse to participate in blood collection at designated time points.",true,"ALL","18 Years",{"count":75,"type":76},200,"ESTIMATED","OBSERVATIONAL","This observational study will evaluate whether a blood test can detect the return of non-small cell lung cancer at least three months before it is identified on routine imaging. The test measures circulating tumor DNA (ctDNA), which consists of small pieces of DNA released by cancer cells into the blood. Detecting ctDNA after treatment may indicate that cancer cells remain in the body, even when cancer is not visible on scans.\n\nApproximately 200 adults with stage IB-IIIA non-small cell lung cancer who are considered candidates for surgery will participate at Fox Chase Cancer Center. Participants will receive standard-of-care treatment selected by their treating physicians, which may include chemotherapy and immunotherapy before or after surgery. Blood samples will be collected before treatment and at scheduled times during treatment and follow-up. Researchers will compare ctDNA results with routine imaging and clinical outcomes to assess how well the test predicts cancer recurrence.\n\nParticipants will be followed for up to five years after surgery, with the primary analysis focused on the first three years. Additional research in a subset of participants will examine blood, tissue, and stool samples to explore relationships among immune responses, gut bacteria, treatment response, and cancer recurrence.",[80],"Non Small Cell Lung Cancer",[82,83,84,85,86],"Non-small cell lung cancer","NSCLC","ctDNA","Circulating tumor DNA","Liquid biopsy","NOT_YET_RECRUITING","2026-09-28",{"date":90,"type":91},"2026-10-02","ACTUAL",{"date":93,"type":76},"2026-10-06",{"date":95,"type":76},"2031-10-05",{"name":5,"class":6}]