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

Recruiting

• Conditions: Primary Central Nervous System Lymphoma (PCNSL); Diffuse Large B-Cell Lymphoma

• Registration Number: NCT07188077
• Lead Sponsor: Ting YANG

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Primary Completion: 2026-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolomics	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	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)

Secondary Outcome Measures

Name	Time	Method
OS	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
PFS	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

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China