Fecal DNA Methylation and Helicobacter Pylori SNPs Tests for Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric (Stomach) Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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Diagnostic 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Dazhi Xu

Director of the gastric surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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2410-Exp092-02

Identifier Type: -

Identifier Source: org_study_id