Fecal DNA Methylation and Helicobacter Pylori SNPs Tests for Gastric Cancer

December 30, 2025 updated by: Dazhi Xu, Fudan University

Application of Fecal DNA Methylation and Fecal Helicobacter Pylori Gastric Cancer Susceptibility Genes in Clinical Diagnosis, Treatment, and Relapse and Metastasis of Gastric Cancer

Based on the detection technology of methylation sites in feces, combined or not combined with Helicobacter pylori gastric cancer susceptibility gene detection, an early diagnosis and detection system for gastric cancer is established, and the clinical diagnostic value of the detection system is evaluated. In addition, the study observed the association between different loci and post-treatment recurrence, metastasis, or long-term survival rate through long-term follow-up of gastric cancer patients; Follow up with individuals with benign diseases such as gastritis and healthy individuals, compare cases of gastric cancer, and compare their sample data during follow-up with controls who did not have the disease.

Study Overview

Status

Active, not recruiting

Conditions

Gastric (Stomach) Cancer

Intervention / Treatment

Diagnostic test: Diagnostic Test: fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

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

Study Locations

China
- - Shanghai, China
    - Fudan University Shanghai Cancer Center

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

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Subjects for this clinical study were obtained from inpatients and outpatient follow-up patients attending the sub-center. Subjects will be identified by the investigator based on subject entry criteria and informed of the contents of the informed consent form. Subjects will have their feces collected at the time of clinic visit or at the time of physical examination and will be tested for fecal methylated DNA and H. pylori gastric cancer susceptibility genes.

Description

Inclusion Criteria:

Age ≥ 18 years old, male or female not limited.
Within 90 days, the gastroscopy and/or pathological results confirm the absence of gastric cancer.
Patients must be able to fully understand the informed consent form and be able to personally sign it.

Exclusion Criteria:

Severe heart, liver, kidney dysfunction, or mental illness.
History of malignant tumors in the upper gastrointestinal tract.
Pregnant women.
Those with unclear pathology.
Those with unsatisfactory sample retention (such as insufficient sample size).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive predictive value of early diagnosis of gastric cancer Time Frame: baseline	baseline

Collaborators and Investigators

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

Sponsor

Fudan University

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)

January 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

June 21, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)