Prospective Gastric Cancer Screening With Fecal Multi-target DNA Analysis

NCT06943807 | Recruiting DMC

• 1 other identifier: 2410-Exp079
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric (Stomach) Cancer

Outcome Measures

Primary Outcomes (1)

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

  To compare the sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer.

  2 years

Secondary Outcomes (4)

• 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

  2 years

• Early diagnosis rate of gastric cancer

  2 years

• Diagnosis rate of precancerous lesions associated with gastric cancer

  2 years

Other Outcomes (1)

• Development of a new screening strategy

  2 years

Interventions

Fecal sample methylation detection for gastric cancer

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant or breastfeeding women.
• Other conditions that the investigator deems inappropriate for participation in the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

People's Hospital of Tongling City

Tongling, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Feces

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Dazhi Xu, PhD

CONTACT

86-18121299796; xudzh@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CN (1)