Fecal DNA Methylation and Helicobacter Pylori SNPs Tests for 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.

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Key information

Conditions

Gastric (Stomach) Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

Positive predictive value of early diagnosis of gastric cancer

Time frame: baseline

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Dec 31, 2025
Registry last updated: Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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