[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xiaohui Ren\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100658453","rapid-diagnosis-and-treatment-response-monitoring-of-primary-cns-lymphoma-using-csf-ctdna-liquid-biopsy-100658453",false,"NCT07851363","Rapid Diagnosis and Treatment Response Monitoring of Primary CNS Lymphoma Using CSF ctDNA Liquid Biopsy","Rapid Diagnosis and Treatment Response Monitoring of Primary Central Nervous System Lymphoma Using Cerebrospinal Fluid Circulating Tumor DNA Liquid Biopsy","Inclusion Criteria:\n\n* Patients with pathologically confirmed primary central nervous system lymphoma;\n* Lesions confined to the central nervous system (cerebral parenchyma, meninges, spinal cord or intraocular), with no evidence of systemic lymphoma;\n* Aged ≥ 18 years and ≤ 75 years, no restriction on gender;\n* Expected survival of more than 3 months;\n* The subjects voluntarily join this study, understand the trial procedures and contents, sign the informed consent form, have good compliance and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Other types of central nervous system tumors;\n* Without pathological confirmation basis;\n* Patients complicated with other malignant tumors;\n* Other conditions that are considered by the investigators to be unsuitable for participating in this trial.","ALL","18 Years","75 Years",{"count":20,"type":21},300,"ESTIMATED","3 Years","OBSERVATIONAL","The incidence of primary central nervous system lymphoma (PCNSL) has increased steadily, and the disease often progresses rapidly, with many patients presenting in critical condition. Timely biopsy and rapid pathological diagnosis are therefore essential for emergency management. However, biopsy is invasive and limited by bleeding risk, surgical contraindications, restricted tissue availability, and the effects of corticosteroid exposure or sampling location on pathological assessment. Moreover, delays inherent in imaging-based evaluation hinder the detection of very early relapse and may adversely affect patient outcomes.\n\nThe investigators have focused on precision diagnosis and treatment of PCNSL, established an emergency-to-pathology rapid-response system and provided preliminary evidence from a small cohort that cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) has distinctive value for diagnosis and treatment-response assessment. A key biomarker-based panel achieved 100% specificity and 85% sensitivity.\n\nThis project aims to establish a large, multicenter, disease-specific PCNSL database and characterize ctDNA alterations across more than 100 genes using ultra-deep sequencing. This project will integrate longitudinal CSF ctDNA profiles collected across disease stages with matched tissue-sequencing data. This approach will delineate the dynamic evolution of ctDNA molecular features and their spatiotemporal relationship with intratumoral heterogeneity. By developing multimodal AI models, the project aims to enable rapid early diagnosis, treatment-response prediction, and longitudinal disease monitoring, while elucidating mechanisms of therapeutic resistance and ultimately improving patient outcomes.",[26],"Primary Central Nervous System Lymphoma",[28,29,30,31],"primary central nervous system lymphoma","cerebrospinal fluid circulating tumor DNA","AI","treatment monitoring","RECRUITING","2026-09-25",{"date":35,"type":36},"2026-10-01","ACTUAL",{"date":38,"type":36},"2026-01-01",{"date":40,"type":21},"2029-12-31",{"name":42,"class":43},"Xiaohui Ren","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100657558","registry-of-an-integrated-longitudinal-multimodal-biospecimen-biobank-for-primary-cns-lymphoma-in-china-climb-100657558","NCT07842835","Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary CNS Lymphoma in China","Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary Central Nervous System Lymphoma in China（CLIMB）","CLIMB","Inclusion Criteria:\n\n* General Criteria for Patient Participants\n* Age ≥18 years.\n* Radiological findings suspicious for primary central nervous system lymphoma (PCNSL).\n* Scheduled to undergo needle biopsy or surgical resection of a lesion involving the brain, spinal cord, or meninges.\n* Willing and able to provide written informed consent.\n* Core PCNSL Cohort\n* Patient participants must additionally meet all of the following criteria:\n* Histopathologically confirmed PCNSL.\n* Able and willing to comply with scheduled study follow-up.\n* Able to undergo magnetic resonance imaging examinations.\n* Non-PCNSL Disease Control Cohort\n* Patient participants must meet the following criterion:\n* Initially suspected of having PCNSL based on imaging findings but ultimately diagnosed with a condition other than PCNSL by histopathological examination.\n* Healthy Control Cohort\n* Age ≥18 years.\n* Eligible for recruitment as a healthy control according to the study screening procedures.\n* Meets the prespecified matching requirements for the study cohorts.\n* Willing and able to provide written informed consent.\n* Additional Criteria for the Longitudinal CSF\u002FPeripheral Blood Subcohort\n* Participants entering this subcohort must additionally meet all of the following criteria:\n* No contraindication to lumbar puncture, as determined by the study physician.\n* Willing and able to undergo serial cerebrospinal fluid and peripheral blood collection.\n* Provides separate explicit informed consent for longitudinal biospecimen collection.\n* Final eligibility for all cohorts will be determined by the study investigator based on the participant's clinical condition, pathological findings, and relevant examination results.\n\nExclusion Criteria:\n\n* Exclusion Criteria for Patient Cohorts\n* PCNSL is suspected based on imaging findings, but no definitive histopathological diagnosis can be obtained.\n* Estimated life expectancy of less than 3 months and, in the investigator's judgment, inability to complete the minimum required clinical data or biospecimen collection.\n* Refusal to provide written informed consent or withdrawal of informed consent.\n* Additional Exclusion Criteria for the Longitudinal CSF\u002FPeripheral Blood Subcohort\n* Participants will be excluded from research lumbar puncture if any of the following conditions are present:\n* Severe coagulation disorder.\n* Marked or severe intracranial hypertension.\n* Evidence of, or substantial risk for, cerebral herniation.\n* Spinal infection or central nervous system infection.\n* Any other definite contraindication to lumbar puncture, as determined by the investigator.\n\nExclusion Criteria for Healthy Controls\n\n* Presence of a severe systemic disease.\n* Any condition that, in the investigator's judgment, makes the individual unsuitable for participation.\n* Refusal to provide written informed consent or withdrawal of informed consent.",true,"100 Years",{"count":56,"type":21},400,"This project aims to establish and prospectively register a longitudinal, multimodal biobank for primary central nervous system lymphoma (PCNSL). The study will primarily enroll patients undergoing needle biopsy or surgical resection of lesions involving the brain, spinal cord, or meninges, with a pathological diagnosis of central nervous system lymphoma. To ensure population homogeneity, patients with PCNSL will constitute the core analysis cohort. Patients with imaging findings suggestive of PCNSL but a final pathological diagnosis other than PCNSL will serve as disease controls, and matched healthy volunteers will be recruited as baseline controls.\n\nAt baseline, biopsy tissue, cerebrospinal fluid (CSF), peripheral blood, urine, saliva, and stool samples will be collected. Follow-up visits will be scheduled at 1 month after biopsy and every 3-6 months thereafter, with contrast-enhanced brain magnetic resonance imaging (MRI) and serial collection of CSF and peripheral blood. After the requirements of routine pathological diagnosis have been met, biopsy specimens will undergo tiered multi-omics profiling according to sample availability and freshness, including whole-exome sequencing, bulk RNA sequencing, single-cell RNA sequencing, metabolomics, spatial transcriptomics, and spatial metabolomics. Analyses of CSF and blood samples will focus on circulating tumor DNA and cell-free RNA (ctDNA\u002FcfRNA), supplemented by conventional cytology, flow cytometry, and other clinical data for longitudinal disease monitoring.\n\nThe project will develop an integrated database incorporating clinical, imaging, pathological, molecular, and biospecimen data. It will characterize the relationships of baseline tissue multi-omics features and longitudinal changes in CSF- and blood-derived ctDNA\u002FcfRNA with treatment response, recurrence prediction, and prognosis. The study will also develop diagnostic and risk-stratification models applicable to patients at our institution, across the region, and potentially throughout mainland China, while establishing standardized operating procedures for biospecimen collection and processing. This work is expected to provide high-quality evidence and a sustainable translational research platform for elucidating the biological heterogeneity of PCNSL, validating liquid-biopsy biomarkers, and optimizing precision follow-up strategies.",[59],"Primary Central Nervous System Lymphoma (PCNSL)",[61,62,63,64,65,66,67,68],"Primary central nervous system lymphoma","Multimodal biobank","Prospective longitudinal cohort","Liquid biopsy","Circulating tumor DNA","Cell-free RNA","Multi-omics","Recurrence prediction",{"date":70,"type":36},"2026-09-30",{"date":35,"type":21},{"date":73,"type":21},"2031-07-31",{"name":42,"class":43},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":44},"100657405","phase-2-zanubrutinib-plus-lenalidomide-for-frail-elderly-patients-with-newly-diagnosed-pcnsl-100657405","NCT07839247","Zanubrutinib Plus Lenalidomide for Frail Elderly Patients With Newly Diagnosed PCNSL","Zanubrutinib Plus Lenalidomide for Frail Elderly Patients With Newly Diagnosed Primary CNS Lymphoma: a Prospective, Single-arm, Phase II Clinical Study","Inclusion Criteria\n\n1. Age ≥ 70 years.\n2. patients classified as \"Frail\"according to the simplified Geriatric Assessment (sGA):\n\n   --ADL ≤ 4 residual functions, or\n   * IADL ≤ 5 residual functions, or\n   * CIRS: ≥ 1 comorbidity of grade 3-4 or \\> 8 comorbidities of grade 2, or\n   * Age ≥ 80 years with \"UNFIT\" profile \"UNFIT\" profile: ADL = 5 residual functions or IADL = 6-7 residual functions, or CIRS: 0 comorbidity of grade 3-4 and 5-8 comorbidities of grade 2.\n3. Voluntary provision of written informed consent.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n5. Considered able to safely undergo lumbar puncture.\n6. Life expectancy of ≥ 3 months, as judged by the investigator.\n7. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) confined to the central nervous system (CNS).\n8. Hematologic function: absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, and platelet count ≥ 80 x 10\\^9\u002FL.\n9. Hepatic function: serum total bilirubin ≤ 1.5 x the upper limit of normal (ULN), and serum alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN.\n10. Renal function: creatinine clearance ≥ 30 mL\u002Fmin, as estimated using the Cockcroft-Gault formula, or serum creatinine ≤ 1.5 x ULN.\n11. Coagulation function: international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.\n12. Female participants of childbearing potential must have a negative pregnancy test within 7 days before the first dose and agree not to donate oocytes for reproductive purposes throughout the treatment and follow-up periods. Their male sexual partners must use condoms during sexual intercourse.\n13. Male participants with female partners of childbearing potential must use condoms during sexual intercourse throughout the study and refrain from donating or cryopreserving sperm during this period.\n14. Participants with stable and adequately controlled comorbidities may be enrolled, including those with hypertension (blood pressure ≤ 160\u002F100 mmHg), type 2 diabetes mellitus (HbA1c ≤ 8%), or mild coronary artery disease without myocardial infarction within the preceding 6 months.\n\nExclusion Criteria\n\n1. Any disease or condition that may impair drug absorption (e.g., active inflammatory gastrointestinal disease, active gastric ulcer, chronic diarrhea, dysphagia, prior gastrectomy, gastroparesis, or short bowel syndrome).\n2. Known hypersensitivity to zanubrutinib, lenalidomide, or any excipient contained in either drug.\n3. Active bleeding within 1 month before treatment; a need for therapeutic anticoagulation during the study (e.g., warfarin or other vitamin K antagonists); or any condition associated with an increased risk of bleeding or coagulopathy (e.g., high-risk esophageal varices or active ulcer disease).\n4. High risk of thrombosis.\n5. Concurrent participation in another interventional clinical study (participation in noninterventional observational studies is permitted).\n6. Major surgery within 4 weeks before treatment or an incompletely healed surgical incision.\n7. Treatment with systemic corticosteroids within 4 weeks before treatment.\n8. Another active malignancy or a history of another malignancy within 5 years before the initiation of study treatment, except for malignancies adequately treated with curative intent, such as basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast.\n9. Receipt of any vaccine, including but not limited to a vaccine against COVID-19, influenza, pneumonia, herpes zoster, or hepatitis B, within 4 weeks before the first dose.\n10. Requirement for treatment with a moderate or strong CYP3A4\u002F5 inhibitor or inducer within 2 weeks before the first dose or during the study;\n11. Stroke or intracranial hemorrhage within 6 months before the first dose.\n12. Known liver disease, including but not limited to alcoholic liver disease, cirrhosis, active hepatitis B virus (HBV) infection (detectable HBV DNA), active hepatitis C virus (HCV) infection (detectable HCV RNA), or other active hepatitis. Participants with HBV DNA below the limit of detection or cured HCV infection are not excluded. Participants with HBV or HCV infection may be enrolled after antiviral therapy, provided that HBV DNA is below the limit of detection or HCV RNA is undetectable, as applicable.\n13. Active syphilis.\n14. Human immunodeficiency virus (HIV) infection\n15. Epstein-Barr virus (EBV) infection\n16. An active infection requiring systemic treatment or unexplained fever with a body temperature ≥ 38.5℃ within 1 week before treatment;\n17. Any of the following cardiac or cardiovascular criteria:\n\n（1）A heart rate-corrected QT interval calculated using Fridericia's formula (QTcF) \\> 470 ms in females or \\> 450 ms in males, or other risk factors for QT-interval prolongation or arrhythmic events (e.g., hypokalemia or a personal or family history of long QT syndrome); （2）A clinically significant arrhythmia or other cardiovascular disease requiring clinical intervention, including but not limited to acute myocardial infarction, unstable angina, or coronary artery bypass grafting within 6 months before treatment; congestive heart failure of New York Heart Association (NYHA) class II or higher; left ventricular ejection fraction (LVEF) \\\u003C 50%; hypertension not controlled with medication (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg); atrial fibrillation of European Heart Rhythm Association (EHRA) class ≥ 2b; or primary cardiomyopathy.\n\n18\\. Prior organ transplantation or allogeneic stem cell transplantation.\n\n19\\. Prior or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or radiation pneumonitis considered by the investigator to render the patient unsuitable for the study.\n\n20\\. An autoimmune disease requiring systemic treatment within the previous 2 years.\n\n21\\. Incomplete clinical data (e.g., no pathology report or inability to undergo MRI or PET\u002FCT assessment).\n\n22\\. Pregnant (positive pregnancy test before dosing) or breastfeeding.\n\n23\\. Any other disease, psychiatric disorder, metabolic abnormality, physical examination finding, or clinically significant laboratory abnormality that, in the investigator's judgment, may compromise the participant's adherence to the study requirements, expose the participant to an unacceptable risk, interfere with the interpretation of the study results, or otherwise render the participant unsuitable for treatment with the study drugs.\n\n24\\. Any other circumstance that, in the investigator's judgment, renders the patient unsuitable for participation in the study.","70 Years",{"count":84,"type":21},33,"INTERVENTIONAL",[87],"PHASE2","This is a prospective, single-arm, phase II clinical study evaluating the efficacy and safety of Zanubrutinib (a BTK inhibitor) plus Lenalidomide (an immunomodulatory drug) in frail elderly patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The study plans to enroll 33 patients who are aged ≥ 70 years and classified as frail, a population for whom standard first-line treatment regimens, high-dose methotrexate-based chemotherapy, may be \"unfit\". This study includes screening phase, induction phase, consolidation phase and maintenance phase. The screening period is defined as within 1 week prior to the first dose. During induction, participants will receive Zanubrutinib 160 mg orally twice daily continuously and Lenalidomide 25 mg orally once daily on days 1-21 of each 28-day cycle for three cycles. Participants who achieve a partial response (PR) or complete response (CR) after induction will receive three additional 28-day consolidation cycles of the same regimen. Participants who achieve a CR after consolidation will continue maintenance treatment with Zanubrutinib and Lenalidomide until disease progression. Treatment response will be assessed throughout the study using the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria and assessed every 3 months. The primary endpoint is the complete response rate (CRR) at the end of induction therapy. Secondary endpoints include overall response rate (ORR) at the end of induction therapy, CRR and ORR at the end of consolidation therapy, One-year and two-year progression-free survival (PFS) rates, Duration of response (DOR), overall survival (OS), adverse event (AE) and serious adverse event (SAE). Exploratory liquid-biopsy analyses will be performed to evaluate treatment response and prognosis.",[59,90,91,92],"Zanubrutinib","Lenalidomide","Frail Elderly",[28,94,95,96,97],"elderly","frail","zanubrutinib","lenalidomide","2026-09-23",{"date":100,"type":36},"2026-09-28",{"date":33,"type":21},{"date":103,"type":21},"2029-08-01",{"name":42,"class":43},""]