Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis

Sponsor
Beijing Friendship Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06109805
Collaborator
(none)
1,200
4
11.4
300
26.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Identification and Multicentral Clinical Validation of Plasma Diagnostic Biomarkers for Gastric Cancer Based on Wide-targeted and Targeted Metabolomics
Actual Study Start Date :
Oct 20, 2023
Anticipated Primary Completion Date :
Mar 20, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm 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 gastric cancer and advanced gastric cancer

Non-gastric cancer group

Patients diagnosed with benign gastric diseases or healthy controls

Outcome Measures

Primary Outcome Measures

  1. Plasma metabolite content [Before receiving treatment for gastric cancer]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Friendship Hospital, Capital Medical University Beijing China
2 Cancer Hospital Chinese Academy of Medical Sciences Beijing China
3 Renmin Hospital of Wuhan University Wuhan China
4 Tongji Hospital, Tongji Medical College of HUST Wuhan China

Sponsors and Collaborators

  • Beijing Friendship Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Min Li, Deputy Director of Science and Technology Department, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT06109805
Other Study ID Numbers:
  • BFHHZML20230010
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2023