💬In plain words
What the trial is, and whether it could suit you
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.
At 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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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