Primary Central Nervous System LymphomaNCT07851363
Rapid Diagnosis and Treatment Response Monitoring of Primary CNS Lymphoma Using CSF ctDNA Liquid Biopsy
An observational study of Primary Central Nervous System Lymphoma, run by Xiaohui Ren at 1 site in China.
Trial summary
The incidence of primary central nervous system lymphoma (PCNSL) has increased steadily, and the disease often progresses rapidly, with many patients presenting in critical condition. Timely biopsy and rapid pathological diagnosis are therefore essential for emergency management. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- HD-MTX-based chemotherapy and BTK inhibitor
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who have radiologically suspected PCNSL
Who may be able to join
- Patients with pathologically confirmed primary central nervous system lymphoma;
- Lesions confined to the central nervous system (cerebral parenchyma, meninges, spinal cord or intraocular), with no evidence of systemic lymphoma;
- Aged ≥ 18 years and ≤ 75 years, no restriction on gender;
- Expected survival of more than 3 months;
- The subjects voluntarily join this study, understand the trial procedures and contents, sign the informed consent form, have good compliance and cooperate with follow-up.
Who cannot join
- Other types of central nervous system tumors;
- Without pathological confirmation basis;
- Patients complicated with other malignant tumors;
- Other conditions that are considered by the investigators to be unsuitable for participating in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 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
About this study
Official title: Rapid Diagnosis and Treatment Response Monitoring of Primary Central Nervous System Lymphoma Using Cerebrospinal Fluid Circulating Tumor DNA Liquid Biopsy
The incidence of primary central nervous system lymphoma (PCNSL) has increased steadily, and the disease often progresses rapidly, with many patients presenting in critical condition. Timely biopsy and rapid pathological diagnosis are therefore essential for emergency management. However, biopsy is invasive and limited by bleeding risk, surgical contraindications, restricted tissue availability, and the effects of corticosteroid exposure or sampling location on pathological assessment. Moreover, delays inherent in imaging-based evaluation hinder the detection of very early relapse and may adversely affect patient outcomes.
The investigators have focused on precision diagnosis and treatment of PCNSL, established an emergency-to-pathology rapid-response system and provided preliminary evidence from a small cohort that cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) has distinctive value for diagnosis and treatment-response assessment. A key biomarker-based panel achieved 100% specificity and 85% sensitivity.
This project aims to establish a large, multicenter, disease-specific PCNSL database and characterize ctDNA alterations across more than 100 genes using ultra-deep sequencing. This project will integrate longitudinal CSF ctDNA profiles collected across disease stages with matched tissue-sequencing data. This approach will delineate the dynamic evolution of ctDNA molecular features and their spatiotemporal relationship with intratumoral heterogeneity. By developing multimodal AI models, the project aims to enable rapid early diagnosis, treatment-response prediction, and longitudinal disease monitoring, while elucidating mechanisms of therapeutic resistance and ultimately improving patient outcomes.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- HD-MTX-based chemotherapy, BTK inhibitor
- Keywords
- primary central nervous system lymphoma, cerebrospinal fluid circulating tumor DNA, AI, treatment monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-MTX-based chemotherapyDrug
High-dose methotrexate-based chemotherapy
BTK inhibitorDrug
Bruton's Tyrosine Kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Radiologically suspected PCNSL | Not described Receives: Drug: HD-MTX-based chemotherapy; Drug: BTK inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: from the first date of administration to the date of tumor progression (up to 36 months)
OS
overall survival
Measured: from the first date of administration to the date of death (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 posted1 Oct 2026
- Study start1 Jan 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion31 Dec 2029 (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 LymphomaStudies 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
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Xiaohui Ren
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
- Responsible party
- Sponsor-investigator, Xiaohui Ren, Beijing Tiantan Hospital
- Investigators
- Xiaohui Ren, Principal investigator, Department of Neurosurgery, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851363
- Sponsor's protocol ID
- CFH 2026-1Q-1113
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 1 Oct 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnosis and Treatment Response Monitoring of Primary Central Nervous System Lymphoma Using Cerebrospinal Fluid Circulating Tumor DNA Liquid Biopsy
- ClinicalTrials.gov ID
- NCT07851363
- Acronym / sponsor ID
- CFH 2026-1Q-1113
- Conditions
- Primary Central Nervous System Lymphoma
- Keywords
- primary central nervous system lymphoma, cerebrospinal fluid circulating tumor DNA, AI, treatment monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xiaohui RenUniversity, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Oct 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.
The incidence of primary central nervous system lymphoma (PCNSL) has increased steadily, and the disease often progresses rapidly, with many patients presenting in critical condition. Timely biopsy and rapid pathological diagnosis are therefore essential for emergency management. However, biopsy is invasive and limited by bleeding risk, surgical contraindications, restricted tissue availability, and the effects of corticosteroid exposure or sampling location on pathological assessment. Moreover, delays inherent in imaging-based evaluation hinder the detection of very early relapse and may adversely affect patient outcomes.
The investigators have focused on precision diagnosis and treatment of PCNSL, established an emergency-to-pathology rapid-response system and provided preliminary evidence from a small cohort that cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) has distinctive value for diagnosis and treatment-response assessment. A key biomarker-based panel achieved 100% specificity and 85% sensitivity.
This project aims to establish a large, multicenter, disease-specific PCNSL database and characterize ctDNA alterations across more than 100 genes using ultra-deep sequencing. This project will integrate longitudinal CSF ctDNA profiles collected across disease stages with matched tissue-sequencing data. This approach will delineate the dynamic evolution of ctDNA molecular features and their spatiotemporal relationship with intratumoral heterogeneity. By developing multimodal AI models, the project aims to enable rapid early diagnosis, treatment-response prediction, and longitudinal disease monitoring, while elucidating mechanisms of therapeutic resistance and ultimately improving patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiologically suspected PCNSL | – | Drug: HD-MTX-based chemotherapy, Drug: BTK inhibitor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have radiologically suspected PCNSL
Key inclusion criteria (5 listed)
- Patients with pathologically confirmed primary central nervous system lymphoma;
- Lesions confined to the central nervous system (cerebral parenchyma, meninges, spinal cord or intraocular), with no evidence of systemic lymphoma;
- Aged ≥ 18 years and ≤ 75 years, no restriction on gender;
- Expected survival of more than 3 months;
- The subjects voluntarily join this study, understand the trial procedures and contents, sign the informed consent form, have good compliance and cooperate with follow-up.
Key exclusion criteria (4 listed)
- Other types of central nervous system tumors;
- Without pathological confirmation basis;
- Patients complicated with other malignant tumors;
- Other conditions that are considered by the investigators to be unsuitable for participating in this trial.
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 |
|---|---|---|
| HD-MTX-based chemotherapyHigh-dose methotrexate-based chemotherapy | Drug | Radiologically suspected PCNSL |
| BTK inhibitorBruton's Tyrosine Kinase inhibitor | Drug | Radiologically suspected PCNSL |
Primary outcome
PFS
Time frame: from the first date of administration to the date of tumor progression (up to 36 months)
progression-free survival
OS
Time frame: from the first date of administration to the date of death (up to 36 months)
overall survival
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 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xiaohui Ren principal investigator
Department of Neurosurgery, Beijing Tiantan Hospital
1 site 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, run by Xiaohui Ren at 1 site 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 5 inclusion and 4 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
PFS (time frame: from the first date of administration to the date of tumor progression (up to 36 months)). The study lists 2 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 1 Oct 2026.