An Observational Study on Gastric Cancer in High-risk Individuals

NCT07438418 | Not Yet Recruiting DMC

• 1 other identifier: GCA-2026-HRIS
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a prospective observational cohort study, aiming to assess the differences in the occurrence of gastric cancer and the progression of gastric cancer-related precancerous lesions between individuals who test positive or negative for fecal multi-target testing, with baseline negative gastric endoscopy results. The clinical outcomes between the two groups will be compared through long-term follow-up.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Difference in the incidence of gastric cancer during a 3-year follow-up

  To compare the difference in the incidence of gastric cancer between groups with positive and negative baseline fecal multi-target testing during a 3-year follow-up.

  During the initial 3-year period of the study

Secondary Outcomes (2)

• Difference in the incidence of gastric cancer at 5-, and 10-year follow-up time points

  From enrollment to the end of the study in 10 years

• Difference in the incidence of precancerous lesions associated with gastric cancer at 3-, 5-, and 10-year follow-up time points

  From enrollment to the end of the study in 10 years

Study Arms (2)

Exposure group

Individuals who are positive for baseline fecal multi-target testing

Diagnostic Test: The result of fecal multi-target DNA testing

Conrol

Individuals who are negative for baseline fecal multi-target testing

Diagnostic Test: The result of fecal multi-target DNA testing

Interventions

The result of fecal multi-target DNA testing DIAGNOSTIC_TEST

By prospectively following individuals who are positive and negative for fecal multi-target testing with baseline negative gastric endoscopy, the incidence of gastric cancer and the progression of gastric precancerous lesions were compared between the two groups.

Conrol; Exposure group

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 from communities in Tongling, Anhui Province.

You may qualify if:

• Age ≥ 40 years, gender is not limited.
• Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.

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

Location

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: February 23, 2026
• First Posted: February 27, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2035
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)