Actively Recruiting
A Prospective Study of Gastric Cancer Screening Based on Fecal Multi-Target DNA Analysis Combined With a Risk Questionnaire
Led by Fudan University · Updated on 2026-02-25
15000
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a multi-target fecal DNA test combined with a gastric cancer risk questionnaire to detect gastric cancer early. This prospective study aims to assess whether detecting Helicobacter pylori genes and fecal methylated DNA markers, individually or together, can help diagnose gastric cancer sooner. The study is conducted by Fudan University and involves residents from selected communities in Tongling City. Participants who join will provide stool samples for the multi-target DNA test and complete a risk questionnaire. Those who test positive on the fecal DNA test or are identified as high-risk by the questionnaire will undergo further diagnostic workup, including fiberoptic endoscopy and pathological biopsy. Individuals not diagnosed with gastric cancer in the first year will enter an annual follow-up program. Residual stool samples will be stored for future biomarker research. During the study, participants will be interviewed face-to-face to complete the questionnaire and provide stool samples. Researchers will measure the sensitivity, specificity, predictive values, and diagnosis rates related to the fecal DNA test and questionnaire over two years. The study will monitor participants through follow-up visits and evaluate outcomes related to early gastric cancer detection and precancerous lesion diagnosis.
CONDITIONS
Brief Title
Prospective Gastric Cancer Screening With Fecal Multi-target DNA Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older, male or female
- No contraindications to endoscopy and able to cooperate with endoscopy
- Able to understand and sign the informed consent form in person
You will not qualify if you...
- History of diagnosed gastric cancer or other malignant tumors of the digestive tract
- Severe underlying conditions like cardiopulmonary insufficiency, liver or renal failure limiting life expectancy or follow-up
- Severe mental illness or inability to participate due to lack of civil behavior
- Pregnant or breastfeeding women
- Other conditions deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to provide stool sample and complete a questionnaire
Duration - Approximately 1 to 2 weeks following screening
Participants who test positive on the fecal multi-target DNA test or are identified as high-risk through the questionnaire undergo a confirmatory diagnostic workup including fiberoptic endoscopy and pathological biopsy.
1 visit (in-person) for endoscopy and biopsy
Duration - Up to 2 years
Screening-positive participants not diagnosed with gastric cancer in the first year will be entered into an annual follow-up program to monitor their condition.
Annual follow-up visits
Trial Site Locations
Total: 1 location
1
People's Hospital of Tongling City
Tongling, China
Actively Recruiting
Research Team
D
Dazhi Xu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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