Gastric Adenocarcinoma
Conditions
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.
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_TESTThe 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.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the incidence of gastric cancer during a 3-year follow-up | During the initial 3-year period of the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
Countries
China
Contacts
CONTACTDazhi Xu, PhD
Outcome results
None listed