Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:38 AM
Study NCT ID:
NCT07438418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study on Gastric Cancer in High-risk Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2035-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the incidence of gastric cancer during a 3-year follow-up', 'timeFrame': 'During the initial 3-year period of the study', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Difference in the incidence of gastric cancer at 5-, and 10-year follow-up time points', 'timeFrame': 'From enrollment to the end of the study in 10 years', 'description': '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.'}, {'measure': 'Difference in the incidence of precancerous lesions associated with gastric cancer at 3-, 5-, and 10-year follow-up time points', 'timeFrame': 'From enrollment to the end of the study in 10 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Adenocarcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nSecondary 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects were recruited from communities in Tongling, Anhui Province.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n1. Age ≥ 40 years, gender is not limited.\n2. Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.\n\nExclusion Criteria:\n\n1. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.\n2. 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.\n3. Severe mental illness or incapacity to participate in the study due to lack of civil behavior.\n4. Pregnant or breastfeeding women.\n5. Other conditions that the investigator deems inappropriate for participation in the study.'}, 'identificationModule': {'nctId': 'NCT07438418', 'briefTitle': 'An Observational Study on Gastric Cancer in High-risk Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Risk of Gastric Cancer in High-risk Individuals: an Observational Cohort Study', 'orgStudyIdInfo': {'id': 'GCA-2026-HRIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposure group', 'description': 'Individuals who are positive for baseline fecal multi-target testing', 'interventionNames': ['Diagnostic Test: The result of fecal multi-target DNA testing']}, {'label': 'Conrol', 'description': 'Individuals who are negative for baseline fecal multi-target testing', 'interventionNames': ['Diagnostic Test: The result of fecal multi-target DNA testing']}], 'interventions': [{'name': 'The result of fecal multi-target DNA testing', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Conrol', 'Exposure group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tongling', 'country': 'China', 'contacts': [{'name': 'Guihe Wang', 'role': 'CONTACT', 'email': '2175613200@qq.com', 'phone': '86-05625838104'}], 'facility': "People's Hospital of Tongling City", 'geoPoint': {'lat': 30.95, 'lon': 117.78333}}], 'centralContacts': [{'name': 'Dazhi Xu, PhD', 'role': 'CONTACT', 'email': 'xudzh@fudan.edu.cn', 'phone': '86-18121299796'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the gastric surgery department', 'investigatorFullName': 'Dazhi Xu', 'investigatorAffiliation': 'Fudan University'}}}}