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NCT Number: NCT07188077

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

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.

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Key information

Conditions

Primary Central Nervous System Lymphoma (PCNSL) Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

晓权 纪

CONTACT

[email protected]

+8618159117171

Sponsors and collaborators

Lead sponsor

Ting YANG

Other

Registry information

Official study title

Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma Based on Metabolomics and Immunomics

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 23, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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