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

NCT07188077 | Recruiting

• 1 other identifier: PCNSL-IMMS-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Metabolomics

  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

  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 Outcomes (2)

• 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

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hematopoietic stem cell donor

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ting YANG: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

晓权 纪

CONTACT

+8618159117171; jxqwd0901@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Administrative Director of the Department

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 23, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CN (1)