Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary CNS Lymphoma in China
Primary Central Nervous System Lymphoma (PCNSL)
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 100 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 400 Estimado
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Acerca de la investigación
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.
¿Quién podría participar?
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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.
Población del estudio
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.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
PCNSL Cohort
Adults with pathologically confirmed primary central nervous system lymphoma (PCNSL) following biopsy or surgical resection of a brain, spinal cord, or meningeal lesion. Clinical, imaging, pathological, treatment, and outcome data will be collected. Tumor tissue, cerebrospinal fluid, peripheral blood, urine, saliva, and stool will be collected at baseline, as available. Eligible consenting participants without contraindications to lumbar puncture may enter a longitudinal biospecimen subcohort, with contrast-enhanced brain MRI and serial cerebrospinal fluid and peripheral blood collection at postoperative Month 1 and every 3-6 months thereafter.
Drug: High-dose methotrexate-based therapy · Drug: Bruton tyrosine kinase inhibitor-based therapy
High-dose methotrexate-based therapy DRUG
Standard-of-care treatment containing high-dose methotrexate as the backbone regimen, administered alone or in combination with other anticancer agents according to the treating physician's judgment and institutional practice. Treatment selection, dose, schedule, combination regimen, and duration are not assigned by the study protocol. Clinical response, recurrence, survival, adverse events, imaging findings, and longitudinal molecular biomarkers will be recorded prospectively.
Bruton tyrosine kinase inhibitor-based therapy DRUG
Standard-of-care treatment containing a Bruton tyrosine kinase inhibitor as a principal therapeutic component, administered alone or in combination with other anticancer agents according to the treating physician's judgment and institutional practice. The specific BTK inhibitor, dose, schedule, combination regimen, and duration are not assigned by the study protocol. Clinical response, recurrence, survival, adverse events, imaging findings, and longitudinal molecular biomarkers will be recorded prospectively.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Baseline data completeness rate
Plazo: At baseline, from enrollment through completion of baseline assessments（up to 30 months）
Percentage of enrolled participants with complete required baseline clinical, imaging, pathological, treatment, and biospecimen information in the electronic case report form. The numerator is the number of participants with all protocol-required baseline data; the denominator is the total number of enrolled participants.
Paired tumor tissue and cerebrospinal fluid sample acquisition rate
Plazo: within 1 month after biopsy or surgery (up to 30 months)
Percentage of eligible participants from whom both evaluable tumor tissue and cerebrospinal fluid samples are successfully collected and stored according to the study standard operating procedures.
Participant follow-up completion rate
Plazo: from enrollment to follow-up at Month 3, 6, 12, 24 and 36 (up to 36 months)
Percentage of enrolled participants who complete the protocol-required clinical and imaging follow-up assessments at Month 12 and Month 24. Completion rates will be calculated separately for each time point.
Adherence to longitudinal cerebrospinal fluid sampling
Plazo: Postoperative Month 1 and every 3-6 months thereafter (up to 36 months)
Percentage of scheduled cerebrospinal fluid collection visits completed among participants enrolled in the longitudinal cerebrospinal fluid/peripheral blood subcohort.
Association between cerebrospinal fluid ctDNA clearance and MRI response
Plazo: 3-6 months after pathological comfirmation (up to 36 months)
Cerebrospinal fluid circulating tumor DNA status will be classified as cleared or not cleared at postoperative Month 3 and compared with concurrent MRI response categories-complete response, partial response, stable disease, or progressive disease. The association or agreement will be assessed using contingency-table analysis, kappa statistics, and/or receiver operating characteristic analysis, as applicable.
Association of baseline and longitudinal ctDNA/cfRNA status with progression-free survival
Plazo: From the prespecified index date through Month 3, 6, 12, 24 and 36 (up to 36 months)
Progression-free survival will be evaluated according to baseline and longitudinal cerebrospinal fluid or peripheral blood ctDNA/cfRNA status. Progression-free survival is the time from the prespecified index date to radiographic or clinical disease progression or death from any cause, whichever occurs first.
Medidas secundarias
Objective response rate
Plazo: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Percentage of evaluable participants achieving complete response or partial response on MRI, summarized according to prespecified baseline tumor multi-omics characteristics.
Best overall response
Plazo: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Best MRI response recorded during follow-up-complete response, partial response, stable disease, or progressive disease-summarized according to baseline tumor multi-omics characteristics.
Progression-free survival
Plazo: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Time from the prespecified index date to radiographic or clinical progression or death from any cause, whichever occurs first, analyzed according to baseline tumor multi-omics characteristics.
Overall survival
Plazo: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Time from the prespecified index date to death from any cause. Participants without a documented death will be censored at the date they were last known to be alive.
Lead time from molecular recurrence detected by cerebrospinal fluid ctDNA to radiographic recurrence
Plazo: Postoperative Month 1 and every 3 months thereafter (up to 36 months)
Number of days between the first post-clearance cerebrospinal fluid ctDNA reappearance or prespecified increase in variant allele fraction and the date of MRI-confirmed disease recurrence. Positive values indicate that molecular recurrence preceded radiographic recurrence.
Concordance and clinical associations of key driver variants in tumor tissue and cerebrospinal fluid
Plazo: At baseline and every 3-6 months after pathological confirmation （up to 36 months）
Concordance of key driver variants, including MYD88, between tumor tissue and cerebrospinal fluid ctDNA, and their associations with pathological subtype, treatment regimen, response, progression, and survival.
Molecular evolution between diagnosis and recurrence
Plazo: From baseline to the first documented recurrence (up to 36 months)
Changes in somatic variants, variant allele fractions, copy-number alterations, transcriptomic features, or other prespecified molecular characteristics between paired diagnostic and recurrence samples.
Change in neurological and performance status
Plazo: At baseline and every 3-6 months thereafter (up to 60 months)
Change from baseline in neurological function and performance status, including Karnofsky Performance Status and/or Eastern Cooperative Oncology Group performance status.
Change in cognitive function
Plazo: At baseline and every 3 months thereafter (up to 60 months)
Change from baseline in cognitive function measured using a prespecified validated cognitive assessment instrument.
Incidence of treatment-related adverse events
Plazo: From enrollment to follow-up (up to 36 months)
Number and percentage of participants experiencing treatment-related adverse events, summarized by event type, severity, and relationship to treatment using a prespecified adverse-event grading system.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (3)
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3 centros
Deparment of neurosurgery, Beijing tiantan hospitalBeijing, Beijing Municipality, ChinaReclutando
Deparment of neurosurgery, Shandong Provincial HospitalShandong, Jinan, ChinaReclutando
Deparment of neurosurgery, Tianjin huanhu hospitalTianjin, Tianjin Municipality, ChinaReclutando
Equipo y fechas
- Patrocinador principal
- Xiaohui Ren
- Inicio del estudio
- 1 oct 2026 Real
- Finalización primaria
- 31 dic 2028 Estimado
- Finalización del estudio
- 31 jul 2031 Estimado
- Primera publicación
- 25 sept 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary Central Nervous System Lymphoma in China（CLIMB）
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026