Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-31 @ 8:03 PM
Study NCT ID:
NCT05387005
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2022-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Strategy for Gastric Cancer Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4403}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2022-05-22', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rates of H. pylori infection', 'timeFrame': '2-8 weeks', 'description': 'The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.'}], 'secondaryOutcomes': [{'measure': 'The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups', 'timeFrame': '2 weeks to 1 year', 'description': 'Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['H. pylori', 'screening'], 'conditions': ['H. Pylori Infection']}, 'descriptionModule': {'briefSummary': 'There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of diagnostic tests in a population-based H. pylori screening and gastric cancer prevention program.\n\nInitially, we planned to recruit 10,000 adults aged ≥20 years who had not previously undergone H. pylori screening or treatment. Eligible participants were to be randomly allocated in a 1:1:1:1 ratio to one of four groups, each receiving a different combination of diagnostic tests. However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B (HpSA method) and Group D (Two-stage screening method). The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A (UBT method) and Group C (standard method) will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.', 'detailedDescription': 'Background: There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies.\n\nObjective: A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of C13 UBT and HpSA in a population-based H. pylori screening and gastric cancer prevention program.\n\nMethods：Open labeled, randomized controlled trial Initially, the investigators will recruit adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients were randomly 1:1:1:1 allocated to (A) The carbon-13 urea breath test (C13 UBT), (B) H. pylori stool antigen test (Vstrip® HpSA), (C) Standard method (Both C13 UBT and HpSA), (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive). However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B and Group D. The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A and Group C will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.\n\nOutcome analysis:\n\n1. Detection rate of H. pylori infection\n2. To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups.\n3. To assess the diagnostic accuracy of these tests.\n4. To verify the compliance(/adherence) and feasibility of this two-stage screening method\n5. Long-term Outcomes: To assess the risk reduction of gastric cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 20 years or older\n* Never screened and treated for H. pylori infection\n\nExclusion Criteria:\n\n* Ever undergone gastrectomy\n* Patients with gastric cancer\n* Have been screened or tested for H. pylori infection\n* Ever received H. pylori eradication therapy\n* Have taken proton pump inhibitor within two weeks\n* Have taken antibiotics within two weeks'}, 'identificationModule': {'nctId': 'NCT05387005', 'briefTitle': 'Screening Strategy for Gastric Cancer Prevention', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Identification of the Optimal Screening Strategy for Gastric Cancer Prevention', 'orgStudyIdInfo': {'id': '202203064RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UBT', 'interventionNames': ['Diagnostic Test: UBT']}, {'type': 'EXPERIMENTAL', 'label': 'HpSA', 'interventionNames': ['Diagnostic Test: HPSA']}, {'type': 'EXPERIMENTAL', 'label': 'Standard method', 'interventionNames': ['Diagnostic Test: UBT and HPSA']}, {'type': 'EXPERIMENTAL', 'label': 'Two-stage screening method', 'interventionNames': ['Diagnostic Test: Serology (two stage)']}], 'interventions': [{'name': 'UBT', 'type': 'DIAGNOSTIC_TEST', 'description': 'H. pylori diagnostic test: C13 urea breath test', 'armGroupLabels': ['UBT']}, {'name': 'HPSA', 'type': 'DIAGNOSTIC_TEST', 'description': 'H. pylori diagnostic test: H. pylori stool antigen test', 'armGroupLabels': ['HpSA']}, {'name': 'UBT and HPSA', 'type': 'DIAGNOSTIC_TEST', 'description': 'H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test', 'armGroupLabels': ['Standard method']}, {'name': 'Serology (two stage)', 'type': 'DIAGNOSTIC_TEST', 'description': 'H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.', 'armGroupLabels': ['Two-stage screening method']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jyh-Ming Liou Liou, MD, PhD', 'role': 'CONTACT', 'email': 'jyhmingliou@gmail.com', 'phone': '886-2-23123456 Ext. 63541'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jyh-Ming Liou, MD,PhD', 'role': 'CONTACT', 'email': 'jyhmingliou@gmail.com', 'phone': '886-2-23123456', 'phoneExt': '63541'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}