Clinical trial Recruiting at 1 site Observational Ages 18 to 75

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.

More Primary Central Nervous System Lymphoma trials

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment300 (estimated)
SponsorBeijing Tiantan Hospital
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedDecember 1, 2028
Study endsDecember 31, 2029
Registry record updatedOctober 1, 2026
Trial IDNCT07851363 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.