Primary Central Nervous System Lymphoma (PCNSL)NCT07188077
Metabolic and Immunomic Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma
An observational study of Primary Central Nervous System Lymphoma (PCNSL) and Diffuse Large B-Cell Lymphoma, run by Ting YANG at 1 site in China.
Trial summary
This study is a prospective cohort study. The case group will include patients with primary central nervous system lymphoma confirmed by imaging and pathology. The control group will include patients with pathologically confirmed diffuse large B-cell lymphoma who have been excluded from central nervous system… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Central Nervous System Lymphoma (PCNSL), Diffuse Large B-Cell Lymphoma
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Mar 2027
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hematopoietic stem cell donor
Who may be able to join
- Aged between 18 and 75 years.
- The case group must have a confirmed diagnosis of primary central nervous system lymphoma (PCNSL) and must not have received any antitumor therapy prior to baseline sample collection.
- Must sign an informed consent form, agree to participate in this study, and provide samples and clinical information as required.
- Case group patients must have complete supporting imaging and pathology data.
Who cannot join
- Presence of other systemic malignancies.
- Presence of severe infections or metabolic disorders.
- Use of antimetabolites or chemotherapy drugs within one week prior to sample collection.
- Pregnant or lactating women.
- Concurrent severe internal medical conditions (e.g., end-stage renal disease, heart failure, liver failure).
- Patients unable to complete study requirements due to psychiatric disorders or cognitive impairment.
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
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
晓权 纪, +8618159117171, jxqwd0901@163.com
晓权 纪, 18159117171, jxqwd0901@163.com
About this study
Official title: Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma Based on Metabolomics and Immunomics
This study is a prospective cohort study. The case group will include patients with primary central nervous system lymphoma confirmed by imaging and pathology. The control group will include patients with pathologically confirmed diffuse large B-cell lymphoma who have been excluded from central nervous system involvement, as well as age- and gender-matched healthy volunteers (hematopoietic stem cell donors). Baseline data (as described below) will be collected. Patients with primary CNS lymphoma will undergo follow-up every 3 months, with immediate follow-up if clinical symptoms arise.
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCNSL | Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System | |
| GDLBCL | Diffuse large B-cell lymphoma of the gastrointestinal tract | |
| DLBCL | Non-Hodgkin's diffuse large B-cell lymphoma not involving the central nervous system or gastrointestinal tract | |
| Health | Healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics
Detection of metabolites in plasma using liquid chromatography-mass spectrometry (LC-MS) technology
Measured: Before the start of the first treatment cycle, at the end of each treatment cycle(each cycle is 28 days)
CYTOF
Immunophenotyping of PBMCs using flow cytometry mass spectrometry (CYTOF)
Measured: Before the start of the first treatment cycle, at the end of each treatment cycle(each cycle is 28 days)
Secondary outcomes (2)
OS
Overall survival
Measured: From date of randomization until the date of the end of follow-up or date of death from any cause, whichever came first, assessed up to 12months
PFS
Progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (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
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ting YANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ting YANG, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188077
- Sponsor's protocol ID
- PCNSL-IMMS-01
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protect patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma Based on Metabolomics and Immunomics
- ClinicalTrials.gov ID
- NCT07188077
- Acronym / sponsor ID
- PCNSL-IMMS-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ting YANGUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 Sep 2025 (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 study is a prospective cohort study. The case group will include patients with primary central nervous system lymphoma confirmed by imaging and pathology. The control group will include patients with pathologically confirmed diffuse large B-cell lymphoma who have been excluded from central nervous system involvement, as well as age- and gender-matched healthy volunteers (hematopoietic stem cell donors). Baseline data (as described below) will be collected. Patients with primary CNS lymphoma will undergo follow-up every 3 months, with immediate follow-up if clinical symptoms arise.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PCNSL | – | –Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System |
| GDLBCL | – | –Diffuse large B-cell lymphoma of the gastrointestinal tract |
| DLBCL | – | –Non-Hodgkin's diffuse large B-cell lymphoma not involving the central nervous system or gastrointestinal tract |
| Health | – | –Healthy control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hematopoietic stem cell donor
Key inclusion criteria (4 listed)
- Aged between 18 and 75 years.
- The case group must have a confirmed diagnosis of primary central nervous system lymphoma (PCNSL) and must not have received any antitumor therapy prior to baseline sample collection.
- Must sign an informed consent form, agree to participate in this study, and provide samples and clinical information as required.
- Case group patients must have complete supporting imaging and pathology data.
Key exclusion criteria (6 listed)
- Presence of other systemic malignancies.
- Presence of severe infections or metabolic disorders.
- Use of antimetabolites or chemotherapy drugs within one week prior to sample collection.
- Pregnant or lactating women.
- Concurrent severe internal medical conditions (e.g., end-stage renal disease, heart failure, liver failure).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolomics
Time frame: Before the start of the first treatment cycle, at the end of each treatment cycle(each cycle is 28 days)
Detection of metabolites in plasma using liquid chromatography-mass spectrometry (LC-MS) technology
CYTOF
Time frame: Before the start of the first treatment cycle, at the end of each treatment cycle(each cycle is 28 days)
Immunophenotyping of PBMCs using flow cytometry mass spectrometry (CYTOF)
2 secondary outcomes
OS
Time frame: From date of randomization until the date of the end of follow-up or date of death from any cause, whichever came first, assessed up to 12months
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12months
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 18 Nov 2025.
- Individual participant dataSharing planned: Undecided. Protect patient privacy
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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.
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 (PCNSL) and Diffuse Large B-Cell Lymphoma, run by Ting YANG 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 4 inclusion and 6 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 18 Nov 2025. 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 晓权 纪 (+8618159117171, jxqwd0901@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics (time frame: Before the start of the first treatment cycle, at the end of each treatment cycle(each cycle is 28 days)). 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 18 Nov 2025.