Identification and Validation of Plasma Diagnostic Biomarkers for Multi-Cancer Based on Metabolomics: A Multi-Center Clinical Research and Validation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,700
- 试验地点
- 4
- 主要终点
- Plasma metabolite content
研究概览
简要总结
The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from multi-cancer patients using advanced mass spectrometry detection technology, in conjunction with metabolomics approaches. The goal is to construct a plasma metabolite database for multi-cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early multi-cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of multi-cancer.
详细描述
Firstly, a wide-targeted metabolomic measurement will be conducted on all samples to identify potential metabolite candidate markers and analyze differences in the metabolic profiles of patients with different types of cancer. Additionally, a comprehensive metabolite database specific to cancer patients will be constructed.
Secondly, Samples will be randomly allocated into modeling and testing cohorts. The modeling cohort will be further divided into training and validation sets. Bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high diagnostic efficacy for cancer.
Ultimately, the testing cohort will be used to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Multi-Cancer Group:
- •Patients with a confirmed diagnosis based on the clinical "gold standard".
- •Collection of plasma samples prior to treatment.
- •Availability of complete clinical data.
- •Control Group:
- •Individuals with no abnormalities in routine physical examinations and relevant clinical tests.
- •Age ≥ 45 years.
- •Availability of complete clinical data.
排除标准
- •Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
- •Coexistence of other systemic tumors.
- •Absence of plasma sample collection before treatment.
- •Pregnancy status.
- •No clear evidence of histopathological diagnosis (not applicable to the control group based on this criterion).
- •Patients with severe acute infections.
- •Patients with severe anemia.
- •Patients with severe liver or kidney dysfunction.
- •Patients with autoimmune deficiency diseases.
- •Patients with Hyperlipidemia.
- •Patients received contrast agent injection before blood draw.
- •Patients with psychiatric disorders.
结局指标
主要结局
Plasma metabolite content
时间窗: Before receiving treatment for cancer
The outcome will be tested by metabolomics detection technology based on mass spectrometry
次要结局
未报告次要终点
研究者
Min Li
Deputy Director of Science and Technology Department
Beijing Friendship Hospital