Prospective Gastric Cancer Screening With Fecal Multi-target DNA Analysis

February 23, 2026 updated by: Dazhi Xu, Fudan University

A Prospective Study of Gastric Cancer Screening Based on Fecal Multi-Target DNA Analysis Combined With a Risk Questionnaire

This is a prospective study designed to evaluate the efficacy of a multi-target fecal DNA test for the early detection of gastric cancer. The test combines Helicobacter pylori gene detection with analysis of fecal methylated DNA markers. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo the multi-target fecal DNA test and complete the gastric cancer risk questionnaire.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sample Selection:

The study will be conducted in selected communities within Tongling City, with a total of 10000-15000 residents recruited

Participants Recruitment:

  • Participation is voluntary. All subjects must provide written informed consent at the time of recruitment.
  • Well-trained investigators will conduct face-to-face interviews to administer the gastric cancer risk questionnaire.

Tests and Follow-up:

  • Initial Screening: All participants will provide a stool sample for the multi-target DNA analysis (including H. pylori susceptibility testing and methylated DNA markers) and complete a questionnaire.
  • Definition of Screening Positive: A participant will be considered screening positive if they test positive on the fecal multi-target DNA test or are identified as high-risk through the questionnaire.
  • Diagnostic Workup: All screening-positive individuals will be referred for a confirmatory diagnostic workup. Briefly, the endoscopist will conduct a fiberoptic endoscopy and perform a pathological biopsy.
  • Follow-up: Screening-positive individuals who are not diagnosed with gastric cancer in the first year will be entered into an annual follow-up program.
  • Biobanking: Residual fecal samples will be stored at the biobank of Fudan University Shanghai Cancer Center for future biomarker research.

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tongling, China
        • Recruiting
        • People's Hospital of Tongling City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Subjects were recruited mainly from communities in Tongling, Anhui Province. The subjects were identified by the investigator based on the enrollment criteria and were informed about the contents of the informed consent form.

Description

Inclusion Criteria:

  1. Age ≥40 years, male or female.
  2. No contraindications to endoscopy and able to cooperate with endoscopy.
  3. Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Exclusion Criteria:

  1. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
  2. Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
  3. Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
  4. Pregnant or breastfeeding women.
  5. Other conditions that the investigator deems inappropriate for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer
Time Frame: 2 years
To compare the sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method
Time Frame: 2 years
To compare the positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method
2 years
Number needed to screen to identify one gastric cancer
Time Frame: 2 years
To calculate and compare the number of participants needed to screen to identify one case of gastric cancer using the fecal DNA test versus the questionnaire.
2 years
Early diagnosis rate of gastric cancer
Time Frame: 2 years
To compare the early gastric cancer detection rate achieved by the fecal multi-target DNA testing and the questionnaire.
2 years
Diagnosis rate of precancerous lesions associated with gastric cancer
Time Frame: 2 years
To compare the detection rate of the fecal multi-target DNA testing and the questionnaire for precancerous lesions associated with gastric cancer
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of a new screening strategy
Time Frame: 2 years
To perform a comprehensive analysis of the performance of all methods and develop an optimized, evidence-based strategy for population-based gastric cancer screening.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2410-Exp079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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