Fecal DNA Methylation and Helicobacter Pylori SNPs Tests for Gastric Cancer

NCT07312500 | Active Not Recruiting

• 1 other identifier: 2410-Exp092-02
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric (Stomach) Cancer

Outcome Measures

Primary Outcomes (1)

• Positive predictive value of early diagnosis of gastric cancer

  baseline

Interventions

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

To establish an early diagnostic test system for gastric cancer based on the methylation site detection technology in feces, with or without the combination of Helicobacter pylori gastric cancer susceptibility gene detection, and then to evaluate the clinical diagnostic value of this test system.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the gastric surgery department

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: December 31, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)