Fecal DNA Methylation Detection for Gastric Cancer

NCT ID: NCT06943807

Last Updated: 2025-06-24

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

NOT_YET_RECRUITING

Total Enrollment

10800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-30

Brief Summary

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The study is a prospective, multicentre, cross-sectional study to evaluate the efficacy of fecal methylation-based testing in comparison with the 'gold standard' imaging tests, such as CT, gastroscopy and/or pathology, for the prediction of gastric cancer in an enrolled population.

Detailed Description

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Aims of the study Primary study aim: To assess the sensitivity and specificity of fecal methylation site-based tests for the prediction 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, negative predictive value of fecal methylation locus test for the prediction of gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumour markers, such as CA19-9, CEA, and CA72-4, etc.; 3. The predictive ability of the combined fecal H. pylori gastric cancer susceptibility test was assessed.

Study design Prospective, multicentre, cross-sectional study. Study period 2 years from the start of the project as approved by the Institutional Ethics Committee.

Target population The target population is over 40 years old in areas with a high incidence of gastric cancer.

Sample size The sample size of this study should not be less than 10,800 cases.

Conditions

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Gastric Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Fecal sample methylation detection for gastric cancer

Detection of gastric cancer-associated methylation sites in fecal samples

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age ≥40 years, male or female.
* Have or will have gastroscopy and/or pathology results.
* No contraindications to endoscopy and able to cooperate with endoscopy.
* Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Exclusion Criteria

* Have severe cardiac, hepatic, or renal insufficiency, or mental disorders.
* Previous history of upper gastrointestinal malignancy.
* Women during pregnancy.
* Those with unspecified pathology.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Dazhi Xu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2014-Exp079

Identifier Type: -

Identifier Source: org_study_id

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