Rapid CSF ctDNA Test and Treatment Monitoring for Primary CNS Lymphoma
Official title: Rapid Diagnosis and Treatment Response Monitoring of Primary Central Nervous System Lymphoma Using Cerebrospinal Fluid Circulating Tumor DNA Liquid Biopsy
Run by Beijing Tiantan Hospital · NCT07851363 · Data updated 2026-11-12
This study tests whether CSF circulating tumor DNA can quickly diagnose primary CNS lymphoma and monitor response to treatment in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 1, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07851363 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 years with pathologically confirmed PCNSL, disease confined to the CNS, and good performance status.
✕Probably not a fit
Patients with systemic lymphoma, other CNS tumors, or poor prognosis may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study builds on a rapid-response CSF ctDNA approach to diagnose PCNSL and track how patients respond to treatment. It includes adults with pathologically confirmed PCNSL whose disease is confined to the CNS, and it uses HD-MTX-based chemotherapy with a BTK inhibitor as part of treatment. The goal is to see if CSF ctDNA patterns correlate with diagnostic results and treatment response, potentially enabling faster decisions in clinical practice. The study leverages an emergency-to-pathology workflow and prior evidence of ctDNA’s diagnostic and monitoring value in PCNSL. Data are collected under careful follow-up to evaluate feasibility and associations with outcomes.
Why it matters
Potential benefit: If successful, CSF ctDNA testing could shorten time to diagnosis and provide a noninvasive way to monitor treatment efficacy.
How similar studies have gone: Previous small cohorts have suggested ctDNA in CSF can aid PCNSL diagnosis and monitoring, but larger validation is needed.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Deparment of neurosurgery, Beijing tiantan hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Xiaohui Ren — Department of Neurosurgery, Beijing Tiantan Hospital
- Study coordinator: Xiaohui Ren, MD
- Email: xiaohuiren@mail.ccmu.edu.cn/xiaohuiren@aliyun.com
- Phone: +86-010-59975567
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Testing a four-drug regimen (methotrexate, rituximab, sintilimab, pirtobrutinib) versus investigator-selected care for newly diagnosed PCNSL
This trial will try a combination of methotrexate, rituximab, sintilimab and pirtobrutinib as first treatment for adults with newly diagnosed primary central nervous system lymphoma to see if it increases complete remissions and is safe compared with standard doctor-selected treatments.
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Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL
In this study, adults with newly diagnosed primary CNS lymphoma try different induction regimens to see which one works best before consolidation therapy.
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This trial tests whether combining epcoritamab and ibrutinib is safe and tolerable for adults with relapsed or refractory primary or secondary central nervous system lymphoma.
-
Tirabrutinib maintenance therapy for patients with primary CNS lymphoma in remission
This study is testing if taking tirabrutinib every day can help people with primary CNS lymphoma stay in remission longer after their initial treatment.
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Glofitamab after obinutuzumab pre-treatment for central nervous system lymphoma
This trial will test if giving glofitamab after a short obinutuzumab pre-treatment is safe and helpful for adults with primary or secondary central nervous system lymphoma.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.