Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-22 @ 5:40 PM
Study NCT ID:
NCT02160860
Status:
COMPLETED
Last Update Posted:
2016-08-16
First Post:
2014-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum will be storage in to -80℃ fridge for further test. other biospecimen will be test at site and disposed.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1997}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-14', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HP Infection Rate Estimation for Shanghai Children', 'timeFrame': 'Sampling complete before June 30, 2014. Lab test finish within 10 weeks. Report release within 3 weeks after all test finished.', 'description': 'Get the population of infection with HP and calculate the infection rate for the sampling group, to estimate the infection rate for whole population of Shanghai children'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacterial Infection Due to Helicobacter Pylori (H. Pylori)']}, 'descriptionModule': {'briefSummary': 'Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.', 'detailedDescription': 'To get an understanding of the Hp infection general situation and provide evidence for Hp control, we are planning to run a free physical examination and lab test for a group of children. We are going to proceed with Hp-IgG test, 13C urea breath test and salivary Hp urea antigen test together to screening and diagnosing it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age 3\\~18 children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 3\\~18\n* Not been Clinical diagnosis of\n\nExclusion Criteria:\n\n* Had antibiotics in the past week\n* Had Bismuth or PPI'}, 'identificationModule': {'nctId': 'NCT02160860', 'briefTitle': 'Epidemiology of Helicobacter Pylori Infection Among Shanghai Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Epidemiology of Helicobacter Pylori Infection Among Shanghai Children', 'orgStudyIdInfo': {'id': 'HY201405-HP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children', 'description': 'Children'}]}, 'contactsLocationsModule': {'locations': [{'zip': '201112', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Pujiang Community Health Service Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'HAUNG Ying, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': "Director of GI Department of Children's Hospital of Fudan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director of Gastroenterology of Children's Hospital of Fudan University", 'investigatorFullName': 'Ying HUANG', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}