NCT07851363 Rapid Diagnosis and Treatment Response Monitoring of Primary CNS Lymphoma Using CSF ctDNA Liquid Biopsy
| NCT ID | NCT07851363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiaohui Ren |
| Condition | Primary Central Nervous System Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-01-01 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The 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. This 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.
Eligibility Criteria
Inclusion Criteria: * Patients with pathologically confirmed primary central nervous system lymphoma; * Lesions confined to the central nervous system (cerebral parenchyma, meninges, spinal cord or intraocular), with no evidence of systemic lymphoma; * Aged ≥ 18 years and ≤ 75 years, no restriction on gender; * Expected survival of more than 3 months; * 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. Exclusion Criteria: * Other types of central nervous system tumors; * Without pathological confirmation basis; * Patients complicated with other malignant tumors; * Other conditions that are considered by the investigators to be unsuitable for participating in this trial.
Contact & Investigator
Xiaohui Ren
PRINCIPAL INVESTIGATOR
Department of Neurosurgery, Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT07851363 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Central Nervous System Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07851363 currently recruiting?
Yes, NCT07851363 is actively recruiting participants. Contact the research team at xiaohuiren@mail.ccmu.edu.cn/xiaohuiren@aliyun.com for enrollment information.
Where is the NCT07851363 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07851363 clinical trial?
NCT07851363 is sponsored by Xiaohui Ren. The principal investigator is Xiaohui Ren at Department of Neurosurgery, Beijing Tiantan Hospital. The trial plans to enroll 300 participants.