Plasma Extracellular Vesicle Quantitative Proteomic Analysis for Early Diagnosis of Upper Gastrointestinal Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 562
- 试验地点
- 3
- 主要终点
- Plasma proteins in patients with esophagus cancer
研究概览
简要总结
This study constitutes a case-control investigation employing a retrospective approach. Plasma samples from individuals with esophageal cancer, benign esophageal diseases, gastric cancer, benign gastric diseases, and a healthy control group were systematically collected. Advanced Data-Independent Acquisition (DIA) proteomics and single-vesicle membrane protein detection techniques were employed to quantify protein content within exosomes. Specific protein biomarkers indicative of early-stage upper gastrointestinal tumors were identified. External validation of these protein markers was conducted using Parallel Reaction Monitoring (PRM) technology on an independent validation cohort. The objective is to establish protein marker predictions for early diagnosis of upper gastrointestinal tumors and prognostication of therapeutic efficacy.
详细描述
This study employs a multicenter, retrospective cohort design, collecting and analyzing plasma and tissue exosome protein data from patients with upper gastrointestinal tumors (Stage I-II), upper gastrointestinal benign diseases, and a healthy control group who have visited Beijing Friendship Hospital, and other relevant sub-center hospitals over the past five years. Concurrently, relevant clinical and pathological information is recorded.
Samples from the training cohort undergo traditional quantitative exosome proteomic analysis (Data-Independent Acquisition, DIA) and single-vesicle membrane protein analysis (PBA). A comprehensive upper gastrointestinal tumor-specific exosome protein database is constructed, incorporating extensive information. Subsequently, bioinformatics methods are employed to conduct in-depth analysis of the extensive protein data, screening for proteins with high specificity for upper gastrointestinal tumors, capable of direct detection on the exosome membrane surface. By establishing and evaluating diagnostic models, we aim to quantify the diagnostic potential of these markers, providing a scientific basis for future early screening methods for upper gastrointestinal tumors.
Finally, external validation of these protein markers in an independent validation cohort ensures their reliability and stability across different patient populations. The academic significance of this research lies in its thorough exploration of exosome proteomics in early cancer diagnosis, offering potential innovative breakthroughs for academic progress and clinical practice in this field.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of upper gastrointestinal cancers or benign upper gastrointestinal diseases through gastroscopy and pathological examination.
- •Collection of plasma samples prior to surgical treatment.
- •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 surgical treatment.
- •Incomplete clinical data.
- •Pregnancy status
结局指标
主要结局
Plasma proteins in patients with esophagus cancer
时间窗: Before receiving treatment for esophagus cancer
The outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology
Plasma proteins in patients with gastric cancer
时间窗: Before receiving treatment for gastric cancer
The outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology
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
