An Observational Study on Gastric Cancer in High-risk Individuals

N/ANot Yet RecruitingNCT07438418

Fudan University3,000 enrolled

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.

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).

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Gastric Adenocarcinoma

Interventions

The result of fecal multi-target DNA testingDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria : 1. Age ≥ 40 years, gender is not limited. 2. Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations. 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.

Locations (1)

People's Hospital of Tongling City

Tongling, China

Outcomes

Primary Outcomes

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.

Time frame: During the initial 3-year period of the study

Secondary Outcomes

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

To compare the difference in the incidence of gastric cancer between groups with positive and negative baseline fecal multi-target testing 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

To compare the difference in the incidence of precancerous lesions associated with gastric cancer between groups with positive and negative baseline fecal multi-target testing at 3-, 5-, and 10-year follow-up time points.

Time frame: From enrollment to the end of the study in 10 years

Central Contacts

Dazhi Xu, PhD

CONTACT

86-18121299796 xudzh@fudan.edu.cn

Data from ClinicalTrials.gov

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