Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Esophagus Cancer
• Intervention / Treatment: Other: Gastric Cancer; Other: Esophagus Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 562

Contacts and Locations

• Study Contact: Name: Li Min, Ph.D.; Phone Number: +86 13552652141; Email: minli@ccmu.edu.cn
• Study Contact Backup: Name: Chenjie Xu, Ph.D.

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Cancer Hospital Chinese Academy of Medical Sciences
    • Contact: Yibin Xie, Ph.D
  • Beijing, China
    • Recruiting
    • Beijing Friendship Hospital, Capital Medical University
    • Contact: Li Min, Ph.D.
    • Principal Investigator: Li Min, Ph.D
    • Sub-Investigator: Chenjie Xu, Ph.D
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
      • Contact: Lianmei Zhao, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population included a range of subjects with upper gastrointestinal cancers and diseases, including patients with malignant and benign upper gastrointestinal diseases and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastric cancer group; Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer	Other: Gastric Cancer; Patients diagnosed with gastric cancer, including early stage gastric and advanced gastric cancer
esophagus cancer group; Patients diagnosed with esophagus cancer, including early esophagus cancer and advanced esophagus cancer	Other: Esophagus Cancer; Patients diagnosed with esophagus cancer, including early esophagus gastric and advanced esophagus cancer
Non-cancer group; Patients diagnosed with benign upper gastrointestinal diseases or healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma proteins in patients with gastric cancer	The outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology	Before receiving treatment for gastric cancer
Plasma proteins in patients with esophagus cancer	The outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology	Before receiving treatment for esophagus cancer

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Li Min, Ph.D., Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Neoplasms; Esophageal Neoplasms
• Other Study ID Numbers: BFHHZML20240006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No