Metabolic and Immunomic Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma

November 15, 2025 updated by: Ting YANG

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • 晓权 纪

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Hematopoietic stem cell donor

Description

Inclusion Criteria:

  1. Aged between 18 and 75 years.
  2. 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.
  3. Must sign an informed consent form, agree to participate in this study, and provide samples and clinical information as required.
  4. Case group patients must have complete supporting imaging and pathology data.

Exclusion Criteria:

  1. Presence of other systemic malignancies.
  2. Presence of severe infections or metabolic disorders.
  3. Use of antimetabolites or chemotherapy drugs within one week prior to sample collection.
  4. Pregnant or lactating women.
  5. Concurrent severe internal medical conditions (e.g., end-stage renal disease, heart failure, liver failure).
  6. Patients unable to complete study requirements due to psychiatric disorders or cognitive impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before the start of the first treatment cycle, at the end of each treatment cycle(each cycle is 28 days)
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)
Before the start of the first treatment cycle, at the end of each treatment cycle(each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Overall survival
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
Progression-free survival
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ting YANG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

September 16, 2025

First Posted (Estimated)

September 23, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 15, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCNSL-IMMS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Protect patient privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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