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

NCT06943781 | Recruiting DMC

• 1 other identifier: 2410-Exp081
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori; Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer

  2 years

• Number needed to screen to identify one gastric cancer

  2 years

• Early diagnosis rate of gastric cancer

  2 years

Interventions

Fecal Helicobacter pylori gastric cancer susceptibility gene test DIAGNOSTIC_TEST

In the early stage of the study, the team used genome-wide association analysis (GWAS) to identify H. pylori specific SNP that are significantly associated with gastric cancer in gastric cancer patients and controls; according to the mutation or not of the SNP loci, the strains were categorized into the high-risk group of gastric cancer and the low-risk group. The status of the SNP locus was detected in portable and non-invasive fecal samples from participants using molecular biology assays for early non-invasive screening and risk assessment of gastric cancer in H. pylori infected patients.

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

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 of the gastric surgery department

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CN (1)