Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary CNS Lymphoma in China

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 100 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

400 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 brain magnetic resonance imaging (MRI) and serial collection of CSF and peripheral blood. After the requirements of routine pathological diagnosis have been met, biopsy specimens will undergo tiered multi-omics profiling according to sample availability and freshness, including whole-exome sequencing, bulk RNA sequencing, single-cell RNA sequencing, metabolomics, spatial transcriptomics, and spatial metabolomics. Analyses of CSF and blood samples will focus on circulating tumor DNA and cell-free RNA (ctDNA/cfRNA), supplemented by conventional cytology, flow cytometry, and other clinical data for longitudinal disease monitoring.

The project will develop an integrated database incorporating clinical, imaging, pathological, molecular, and biospecimen data. It will characterize the relationships of baseline tissue multi-omics features and longitudinal changes in CSF- and blood-derived ctDNA/cfRNA with treatment response, recurrence prediction, and prognosis. The study will also develop diagnostic and risk-stratification models applicable to patients at our institution, across the region, and potentially throughout mainland China, while establishing standardized operating procedures for biospecimen collection and processing. This work is expected to provide high-quality evidence and a sustainable translational research platform for elucidating the biological heterogeneity of PCNSL, validating liquid-biopsy biomarkers, and optimizing precision follow-up strategies.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Study population

The study population will be drawn from patients evaluated for suspected primary central nervous system lymphoma at participating tertiary referral hospitals in mainland China, including Beijing Tiantan Hospital, Shandong Provincial Hospital, and Tianjin Huanhu Hospital. Participants will be identified through departments of neurosurgery, hematology, neuro-oncology, radiology, and pathology. Healthy controls will be recruited from the participating institutions and surrounding communities to provide reference biospecimens and molecular profiles. The study will include a core PCNSL cohort, a non-PCNSL disease-control cohort, and a nested longitudinal cerebrospinal fluid/peripheral blood subcohort.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (3)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

3 locations

Study team and timeline

Lead sponsor

Xiaohui Ren

Study start

Oct 1, 2026 Actual

Primary completion

Dec 31, 2028 Estimated

Study completion

Jul 31, 2031 Estimated

First posted

Sep 25, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts