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Clinical Trials/NCT06109805
NCT06109805
Completed
Not Applicable

Identification and Multicentral Clinical Validation of Plasma Diagnostic Biomarkers for Gastric Cancer Based on Wide-targeted and Targeted Metabolomics

Beijing Friendship Hospital4 sites in 1 country1,706 target enrollmentOctober 20, 2023
ConditionsGastric Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Beijing Friendship Hospital
Enrollment
1706
Locations
4
Primary Endpoint
Plasma metabolite content
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from gastric cancer patients using advanced mass spectrometry detection technology, in conjunction with both broad-spectrum and targeted metabolomics approaches. The goal is to construct a dedicated plasma metabolite database for gastric cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early gastric cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of gastric cancer.

Detailed Description

Firstly, a wide-targeted metabolomic measurement will be conducted on plasma samples from the discovery cohort to identify potential metabolite candidate markers and construct a gastric cancer patient-specific metabolite database with extensive metabolite information. Secondly, a more precise targeted metabolomic measurement will be conducted in the modeling cohort. Bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high gastric cancer-specific diagnostic efficacy. Ultimately, an external validation cohort will be introduced to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.

Registry
clinicaltrials.gov
Start Date
October 20, 2023
End Date
February 18, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Min Li

Deputy Director of Science and Technology Department

Beijing Friendship Hospital

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of gastric cancer or benign gastric 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.

Outcomes

Primary Outcomes

Plasma metabolite content

Time Frame: Before receiving treatment for gastric cancer

The outcome will be tested by metabolomics detection technology based on mass spectrometry

Study Sites (4)

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