An Observational Study on Gastric Cancer in High-risk Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The result of fecal multi-target DNA testing.
- Who it may be relevant to
- Registry conditions: Gastric Adenocarcinoma. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk of Gastric Cancer in High-risk Individuals: an Observational Cohort Study
Overview
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.
Detailed description
Primary study objective: to compare the differences in gastric cancer incidence between the two groups (individuals who are positive and negative for baseline fecal multi-target testing).
Secondary study objective: to compare the differences in gastric precancerous lesions incidence between the two groups (individuals who are positive and negative for baseline fecal multi-target testing).
Interventions
- Diagnostic test The result of fecal multi-target DNA testing
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.
Primary outcome measures
- Difference in the incidence of gastric cancer during a 3-year follow-up [Time frame: During the initial 3-year period of the study]
Secondary outcome measures (2)
- Difference in the incidence of gastric cancer at 5-, and 10-year follow-up time points [Time frame: 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 [Time frame: From enrollment to the end of the study in 10 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 40 years, gender is not limited.
- Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- People's Hospital of Tongling City — Tongling
Identifiers
NCT: NCT07438418 · GCA-2026-HRIS