Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis

October 26, 2023 updated by: Min Li, Beijing Friendship Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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.
        • Sub-Investigator:
          • Liyi Bai, M.D.
      • Wuhan, China
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
          • Xu Zhu, Ph.D.
      • Wuhan, China
        • Recruiting
        • Tongji Hospital, Tongji Medical College of HUST
        • Contact:
          • Fayong Hu, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 gastric and non-gastric cancer, including patients with benign gastric disease and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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 gastric cancer and advanced gastric cancer
Non-gastric cancer group
Patients diagnosed with benign gastric diseases or healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma metabolite content
Time Frame: Before receiving treatment for gastric cancer
The outcome will be tested by metabolomics detection technology based on mass spectrometry
Before receiving treatment for gastric cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Estimated)

March 20, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFHHZML20230010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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