Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278064
• Other study ID #: BFHHZML20240006
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Beijing Friendship Hospital
• Contact: Li Min, Ph.D.
• Phone: +86 13552652141
• Email: minli[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 562
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer
• Gastric Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• Gastric Cancer
Patients diagnosed with gastric cancer, including early stage gastric and advanced gastric cancer
• Esophagus Cancer
Patients diagnosed with esophagus cancer, including early esophagus gastric and advanced esophagus cancer

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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