RecruitingNot Applicable

Prospective Gastric Cancer Screening With Fecal Multi-target DNA Analysis

China15,000 participantsStarted 2025-07-01

Plain-language summary

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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥40 years, male or female.
. 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

. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
. 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.
. Severe mental illness or incapacity to participate in the study due to lack of civil behavior.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer

Timeframe: 2 years

Trial details

NCT IDNCT06943807

SponsorFudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-30

Contact for this trial

Dazhi Xu, PhD

86-18121299796 xudzh@fudan.edu.cn

View on ClinicalTrials.gov More Gastric (Stomach) Cancer trials