Metabolic and Immunomic Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Central Nervous System Lymphoma (PCNSL), Diffuse Large B-Cell Lymphoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma Based on Metabolomics and Immunomics
Overview
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.
Primary outcome measures
- Metabolomics [Time frame: 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)]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Fujian Medical University — Fuzhou
Identifiers
NCT: NCT07188077 · PCNSL-IMMS-01