Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test

June 21, 2025 updated by: Dazhi Xu, Fudan University

Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes for the Early Diagnosis and Screening of Gastric Cancer

This is a multicenter, cross-sectional study. It is based on fecal methylation site detection, H. pylori susceptibility testing of fecal samples, and a combination of the two, compared with the "gold standard" imaging tests, CT, gastroscopy and/or pathology, for gastric cancer, benign diseases such as gastritis, and health check-ups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary study objective: to evaluate the sensitivity and specificity of fecal methylation site-based and fecal Helicobacter pylori gastric cancer susceptibility gene assays applied to early diagnosis and screening of gastric cancer.

Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, and negative predictive value of fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing applied for predicting gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumor markers, such as CA19-9, CEA, and CA72-4; and 3. the follow up of Gastritis and healthy people, to assess the cases of gastric cancer during the follow-up period and the clinical diagnosis and treatment prediction; 4. Follow-up gastric cancer patients, to assess the association with gastric cancer recurrence metastasis and treatment.

Study Type

Observational

Enrollment (Estimated)

9654

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

The subjects of this clinical study are from the community population in the high incidence area of gastric cancer in Tongling. The subjects will collect feces during medical visits or physical examinations, and undergo fecal methylation DNA and Helicobacter pylori gastric cancer susceptibility gene testing. The researchers determine the study subjects based on the inclusion and exclusion criteria and inform them of the content of the informed consent form.

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 cardiac, hepatic, or renal insufficiency, or psychiatric disorders.
  • A previous history of malignant tumors of the upper gastrointestinal tract.
  • Women during pregnancy.
  • Those with undefined pathology.
  • Those with unsatisfactory sample retention (e.g., too small a 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
Measure Description
Time Frame
Sensitivity and specificity
Time Frame: Baseline
Sensitivity and specificity of fecal DNA methylation detection and Helicobacter pylori gastric cancer susceptibility genes based on their application for early diagnosis and screening of gastric cancer.
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 (Estimated)

December 1, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 21, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2410-Exp092

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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