Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma Based on Metabolomics and Immunomics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Metabolomics
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Metabolomics
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
Ting YANG
Administrative Director of the Department
Fujian Medical University