Prospective Gastric Cancer Screening Using Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection

Research on the Application of Fecal Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection in the Early Diagnosis and Screening of Gastric Cancer

This is a prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo fecal H. pylori gastric cancer susceptibility testing and complete the gastric cancer risk questionnaire.

Study Overview

• Status: Recruiting
• Conditions: Gastric Adenocarcinoma; Helicobacter Pylori
• Intervention / Treatment: Diagnostic test: Fecal Helicobacter pylori gastric cancer susceptibility gene test

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 fecal H. pylori gastric cancer susceptibility testing and complete a questionnaire.
• Definition of Screening Positive: A participant will be considered screening positive if they test positive on the H. pylori gastric cancer susceptibility testing 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

• Study Contact: Name: Dazhi Xu, PhD; Phone Number: 86-18121299796; Email: xudzh@fudan.edu.cn

Study Locations

• China
  • Tongling, China
    • Recruiting
    • People's Hospital of Tongling City
    • Contact: Guihe Wang; Phone Number: 86-05625838104; Email: 2175613200@qq.com

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire for gastric cancer	To compare the sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer	To compare the positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening methods for gastric cancer	2 years
Number needed to screen to identify one gastric cancer	To compare the number of participants needed to screen identify one gastric cancer for different methods	2 years
Early diagnosis rate of gastric cancer	To compare the early gastric cancer detection rate achieved by the fecal H. pylori gastric cancer susceptibility testing and the questionnaire screening.	2 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 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: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2410-Exp081

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