Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 2:01 PM
Study NCT ID:
NCT04636866
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2020-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prevalence of Helicobacter Pylori in Shanghai, 2013 to 2019
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-14', 'studyFirstSubmitDate': '2020-11-14', 'studyFirstSubmitQcDate': '2020-11-14', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prevalence of Helicobacter pylori and peptic ulcer', 'timeFrame': '2013.1.1-2019.12.31', 'description': 'the trends change from 2013 to 2019'}, {'measure': 'the ration of Helicobacter pylori positive peptic ulcers', 'timeFrame': '2013.1.1-2019.12.31', 'description': 'the trends change from 2013 to 2019'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peptic Ulcer', 'Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'The study was a cross-sectional single-center study, conducted at Renji Hospital, Shanghai Jiaotong university school of medicine. We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy from January 1, 2013 through December 31, 2019. The medical records were analyzed for the prevalence of H. pylori infection in patients with peptic ulcers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy because of uninvestigated dyspepsia from January 1, 2013 through December 31, 2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients who had undergone upper gastrointestinal endoscopy in Renji Hospital because of uninvestigated dyspepsia during 2013 and 2019 were analyzed.\n\nExclusion Criteria:\n\nPatients that underwent upper endoscopy for reasons other than uninvestigated dyspepsia such as cirrhosis follow-up, major systemic diseases or other indications were excluded. Exclusions also included absence of biopsies, unknown H. pylori status and acute ulcer bleeding.'}, 'identificationModule': {'nctId': 'NCT04636866', 'briefTitle': 'The Prevalence of Helicobacter Pylori in Shanghai, 2013 to 2019', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'The Prevalence of Helicobacter Pylori Infection in Patients With Peptic Ulcer Disease in Shanghai, 2013 to 2019', 'orgStudyIdInfo': {'id': 'shrj202010171'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric ulcer', 'interventionNames': ['Other: NO intervention']}, {'label': 'Duodenal ulcer', 'interventionNames': ['Other: NO intervention']}], 'interventions': [{'name': 'NO intervention', 'type': 'OTHER', 'description': 'NO intervention', 'armGroupLabels': ['Duodenal ulcer', 'Gastric ulcer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'HONG LU, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Hong Lu, MD', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}