Primary Central Nervous System Lymphoma (PCNSL)CLIMBNCT07842835
Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary CNS Lymphoma in China
An observational study of Primary Central Nervous System Lymphoma (PCNSL), run by Xiaohui Ren at 3 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Central Nervous System Lymphoma (PCNSL)
- What is being tested?
- High-dose methotrexate-based therapy and Bruton tyrosine kinase inhibitor-based therapy
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- 1 Oct 2026to 31 Jul 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 24Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Deparment of neurosurgery, Beijing tiantan hospital
Beijing, Beijing Municipality, 100070
Xiaohui Ren, MD, +86-010-59975567, xiaohuiren@mail.ccmu.edu.cn/xiaohuiren@aliyun.com
Haoyi Li, MD, +86-010-59975567, lee_627269051@163.com
- Recruiting
Deparment of neurosurgery, Shandong Provincial Hospital
Shandong, Jinan, 250021
Yingchao Liu, MD, +86 13805311573, yingchaoliu@email.sdu.edu.cn
- Recruiting
Deparment of neurosurgery, Tianjin huanhu hospital
Tianjin, Tianjin Municipality, 300222
Hu Wang, MD, +86 13820911123, hwanghu@hotmail.com
About this study
Official title: Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary Central Nervous System Lymphoma in China（CLIMB）
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.
- Being tested
- High-dose methotrexate-based therapy, Bruton tyrosine kinase inhibitor-based therapy
- Keywords
- Primary central nervous system lymphoma, Multimodal biobank, Prospective longitudinal cohort, Liquid biopsy, Circulating tumor DNA, Cell-free RNA, Multi-omics, Recurrence prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose methotrexate-based therapyDrug
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 therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: High-dose methotrexate-based therapy; Drug: Bruton tyrosine kinase inhibitor-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline data completeness rate
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.
Measured: At baseline, from enrollment through completion of baseline assessments（up to 30 months）
Paired tumor tissue and cerebrospinal fluid sample acquisition rate
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.
Measured: within 1 month after biopsy or surgery (up to 30 months)
Participant follow-up completion rate
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.
Measured: from enrollment to follow-up at Month 3, 6, 12, 24 and 36 (up to 36 months)
Adherence to longitudinal cerebrospinal fluid sampling
Percentage of scheduled cerebrospinal fluid collection visits completed among participants enrolled in the longitudinal cerebrospinal fluid/peripheral blood subcohort.
Measured: Postoperative Month 1 and every 3-6 months thereafter (up to 36 months)
Association between cerebrospinal fluid ctDNA clearance and MRI response
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.
Measured: 3-6 months after pathological comfirmation (up to 36 months)
Association of baseline and longitudinal ctDNA/cfRNA status with progression-free survival
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.
Measured: From the prespecified index date through Month 3, 6, 12, 24 and 36 (up to 36 months)
Secondary outcomes (10)
Objective response rate
Percentage of evaluable participants achieving complete response or partial response on MRI, summarized according to prespecified baseline tumor multi-omics characteristics.
Measured: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Best overall response
Best MRI response recorded during follow-up-complete response, partial response, stable disease, or progressive disease-summarized according to baseline tumor multi-omics characteristics.
Measured: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Progression-free survival
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.
Measured: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Overall survival
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.
Measured: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Lead time from molecular recurrence detected by cerebrospinal fluid ctDNA to radiographic recurrence
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.
Measured: Postoperative Month 1 and every 3 months thereafter (up to 36 months)
Concordance and clinical associations of key driver variants in tumor tissue and cerebrospinal fluid
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.
Measured: At baseline and every 3-6 months after pathological confirmation （up to 36 months）
Molecular evolution between diagnosis and recurrence
Changes in somatic variants, variant allele fractions, copy-number alterations, transcriptomic features, or other prespecified molecular characteristics between paired diagnostic and recurrence samples.
Measured: From baseline to the first documented recurrence (up to 36 months)
Change in neurological and performance status
Change from baseline in neurological function and performance status, including Karnofsky Performance Status and/or Eastern Cooperative Oncology Group performance status.
Measured: At baseline and every 3-6 months thereafter (up to 60 months)
Change in cognitive function
Change from baseline in cognitive function measured using a prespecified validated cognitive assessment instrument.
Measured: At baseline and every 3 months thereafter (up to 60 months)
Incidence of treatment-related adverse events
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.
Measured: From enrollment to follow-up (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System Lymphoma (PCNSL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Xiaohui Ren
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Tianjin Huanhu Hospital
- Responsible party
- Sponsor-investigator, Xiaohui Ren, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842835
- Sponsor's protocol ID
- HX-C-2026006
- Acronym
- CLIMB
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary Central Nervous System Lymphoma in China（CLIMB）
- ClinicalTrials.gov ID
- NCT07842835
- Acronym / sponsor ID
- CLIMB / HX-C-2026006
- Keywords
- Primary central nervous system lymphoma, Multimodal biobank, Prospective longitudinal cohort, Liquid biopsy, Circulating tumor DNA, Cell-free RNA, Multi-omics, Recurrence prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xiaohui RenUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Tianjin Huanhu Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCNSL Cohort | – | Drug: High-dose methotrexate-based therapy, Drug: Bruton tyrosine kinase inhibitor-based therapyAdults 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose methotrexate-based therapyStandard-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. | Drug | PCNSL Cohort |
| Bruton tyrosine kinase inhibitor-based therapyStandard-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. | Drug | PCNSL Cohort |
Primary outcome
Baseline data completeness rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
10 secondary outcomes
Objective response rate
Time frame: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Best overall response
Time frame: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Progression-free survival
Time frame: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Overall survival
Time frame: From treatment initiation to follow-up at month 3,6,12,24 and 36 (up to 36 months)
Lead time from molecular recurrence detected by cerebrospinal fluid ctDNA to radiographic recurrence
Time frame: Postoperative Month 1 and every 3 months thereafter (up to 36 months)
Concordance and clinical associations of key driver variants in tumor tissue and cerebrospinal fluid
Time frame: At baseline and every 3-6 months after pathological confirmation （up to 36 months）
Molecular evolution between diagnosis and recurrence
Time frame: From baseline to the first documented recurrence (up to 36 months)
Change in neurological and performance status
Time frame: At baseline and every 3-6 months thereafter (up to 60 months)
Change in cognitive function
Time frame: At baseline and every 3 months thereafter (up to 60 months)
Incidence of treatment-related adverse events
Time frame: From enrollment to follow-up (up to 36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Central Nervous System Lymphoma (PCNSL)
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingPhase 1
Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma
RecruitingPhase 2
A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma
Lymphoma
RecruitingPhase 1
Phase Ib Clinical Study of Keynatinib
Lymphoma, B-Cell
RecruitingPhase 3
IGNITE: Study of Tirabrutinib vs Rituximab and Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Relapsed/Refractory Primary Central Nervous System Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Central Nervous System Lymphoma (PCNSL), run by Xiaohui Ren at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui Ren, MD (+86-010-59975567, xiaohuiren@mail.ccmu.edu.cn/xiaohuiren@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline data completeness rate (time frame: At baseline, from enrollment through completion of baseline assessments（up to 30 months）). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.