Fecal DNA Methylation and Helicobacter Pylori SNPs Tests for Gastric Cancer

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07312500

Enrollment

3000

Registered

2025-12-31

Start date

2025-01-01

Completion date

2027-12-30

Last updated

2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric (Stomach) Cancer

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.

Interventions

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

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.

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Age ≥ 18 years old, male or female not limited. 2. Within 90 days, the gastroscopy and/or pathological results confirm the absence of gastric cancer. 3. Patients must be able to fully understand the informed consent form and be able to personally sign it.

Exclusion criteria

1. Severe heart, liver, kidney dysfunction, or mental illness. 2. History of malignant tumors in the upper gastrointestinal tract. 3. Pregnant women. 4. Those with unclear pathology. 5. Those with unsatisfactory sample retention (such as insufficient sample size).

Design outcomes

Primary

Measure	Time frame
Positive predictive value of early diagnosis of gastric cancer	baseline

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026