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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07188077
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ting YANG
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Central Nervous System Lymphoma (PCNSL), Diffuse Large B-Cell Lymphoma

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fuzhou 1810821, Fujian 1811017, China

Status

Recruiting

Address

The First Affiliated Hospital of Fujian Medical University

Fuzhou 1810821, Fujian 1811017,

Site Contact

晓权纪

[email protected]

+8618159117171

Clinical Trial Finder