Biobank Registry for Primary CNS Lymphoma in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry prospectively enrolls adults undergoing biopsy or surgery for suspected CNS lymphoma, focusing on a core PCNSL cohort confirmed by pathology. It collects tissue, CSF, blood, urine, saliva, and stool at baseline, with follow-up visits tied to imaging and repeated biospecimen collection. The study aims to create a longitudinal, multimodal biobank including potential liquid biopsy markers like circulating tumor DNA, alongside clinical and radiographic data. Healthy controls and disease controls (suspected PCNSL but pathologically non-PCNSL) are enrolled to support comparative analyses. Centers across Beijing, Shandong, and Tianjin participate under a shared protocol, with data and biospecimens stored for future research use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* General Criteria for Patient Participants
* Age ≥18 years.
* Radiological findings suspicious for primary central nervous system lymphoma (PCNSL).
* Scheduled to undergo needle biopsy or surgical resection of a lesion involving the brain, spinal cord, or meninges.
* Willing and able to provide written informed consent.
* Core PCNSL Cohort
* Patient participants must additionally meet all of the following criteria:
* Histopathologically confirmed PCNSL.
* Able and willing to comply with scheduled study follow-up.
* Able to undergo magnetic resonance imaging examinations.
* Non-PCNSL Disease Control Cohort
* Patient participants must meet the following criterion:
* Initially suspected of having PCNSL based on imaging findings but ultimately diagnosed with a condition other than PCNSL by histopathological examination.
* Healthy Control Cohort
* Age ≥18 years.
* Eligible for recruitment as a healthy control according to the study screening procedures.
* Meets the prespecified matching requirements for the study cohorts.
* Willing and able to provide written informed consent.
* Additional Criteria for the Longitudinal CSF/Peripheral Blood Subcohort
* Participants entering this subcohort must additionally meet all of the following criteria:
* No contraindication to lumbar puncture, as determined by the study physician.
* Willing and able to undergo serial cerebrospinal fluid and peripheral blood collection.
* Provides separate explicit informed consent for longitudinal biospecimen collection.
* 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.

Exclusion Criteria:

* Exclusion Criteria for Patient Cohorts
* PCNSL is suspected based on imaging findings, but no definitive histopathological diagnosis can be obtained.
* 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.
* Refusal to provide written informed consent or withdrawal of informed consent.
* Additional Exclusion Criteria for the Longitudinal CSF/Peripheral Blood Subcohort
* Participants will be excluded from research lumbar puncture if any of the following conditions are present:
* Severe coagulation disorder.
* Marked or severe intracranial hypertension.
* Evidence of, or substantial risk for, cerebral herniation.
* Spinal infection or central nervous system infection.
* Any other definite contraindication to lumbar puncture, as determined by the investigator.

Exclusion Criteria for Healthy Controls

* Presence of a severe systemic disease.
* Any condition that, in the investigator's judgment, makes the individual unsuitable for participation.
* Refusal to provide written informed consent or withdrawal of informed consent.

Where it's running

• Deparment of neurosurgery, Beijing tiantan hospital
  Beijing, Beijing Municipality, China Recruiting
• Deparment of neurosurgery, Shandong Provincial Hospital
  Shandong, Jinan, China Recruiting
• Deparment of neurosurgery, Tianjin huanhu hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• 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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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.