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临床试验/NCT06278064
NCT06278064招募中不适用

Plasma Extracellular Vesicle Quantitative Proteomic Analysis for Early Diagnosis of Upper Gastrointestinal Cancers

Beijing Friendship Hospital3 个研究点 分布在 1 个国家目标入组 562 人开始时间: 2024年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Min Li

Deputy Director of Science and Technology Department

Beijing Friendship Hospital

研究点 (3)

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