Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis
Plasma Extracellular Vesicle Quantitative Proteomic Analysis for Early Diagnosis of Upper Gastrointestinal Cancers
1 other identifier
observational
562
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedFebruary 26, 2024
February 1, 2024
11 months
February 19, 2024
February 19, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Gastric cancer group
Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer
esophagus cancer group
Patients diagnosed with esophagus cancer, including early esophagus cancer and advanced esophagus cancer
Non-cancer group
Patients diagnosed with benign upper gastrointestinal diseases or healthy controls
Interventions
Patients diagnosed with gastric cancer, including early stage gastric and advanced gastric cancer
Patients diagnosed with esophagus cancer, including early esophagus gastric and advanced esophagus cancer
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Biospecimen
Only proteins will be detected and analyzed in this study.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Min, Ph.D.
Beijing Friendship Hospital
Central Study Contacts
Chenjie Xu, Ph.D.
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director of Science and Technology Department
Study Record Dates
First Submitted
February 19, 2024
First Posted
February 26, 2024
Study Start
February 1, 2024
Primary Completion
December 31, 2024
Study Completion
June 30, 2025
Last Updated
February 26, 2024
Record last verified: 2024-02