Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-02 @ 4:08 AM
Study NCT ID:
NCT04037904
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2019-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 490}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2019-07-28', 'studyFirstSubmitQcDate': '2019-07-29', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-1B and H+,K+-ATPase mRNA expression', 'timeFrame': '1 year', 'description': 'Gastric Interleukin-1B and H+,K+-ATPase mRNA expression in subjects with and without H. pylori infection at baseline, and changes of Interleukin-1B and H+,K+-ATPase mRNA expression with time in subjects without H. pylori infection and subjects who underwent H. pylori eradication successfully.\n\nGastric Interleukin-1B and H+,K+-ATPase mRNA expression measured by reverse transcription polymerase chain reaction, using the gastric mucosa specimen obtained during esophagogastroduodenoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Interleukin-1 beta', 'Gastric H+, K+- APTase'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'We will evaluate the long-term changes of gastric H+, K+-adenosine triphosphatase (H+, K+-ATPase) and Interleukin-1B mRNA expression according to Helicobacter pylori (H.pylori) infection and intestinal metaplasia and investigate the long-term effect of H. pylori eradication', 'detailedDescription': 'H. pylori suppresses gastric acid secretion by repressing gastric acid pump, H+, K+-ATPase, and stimulating Interleukin-1B. In this study, we will evaluate the expression of H+, K+-ATPase and Interleukin-1B mRNA according to H. pylori infection and intestinal metaplasia in controls and patients with gastric cancer. In addition, we observe the changes of H+, K+-ATPase and Interleukin-1B mRNA expression over 5 years after H. pylori eradication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Controls and patients with gastric dysplasia or gastric cancer who received esophagogastroduodenoscopy and underwent H. pylori tests', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Controls who did not have any evidence of gastric cancer, gastric dysplasia, esophageal tumor, peptic ulcer and lymphoma on esophagogastroduodenoscopy\n* Patients with gastric dysplasia or gastric cancer who diagnosed with gastric dysplasia or early gastric cancer in the final pathological report\n\nExclusion Criteria:\n\n* Subjects with previous eradication treatment for H. pylori\n* Subjects with previous gastrectomy'}, 'identificationModule': {'nctId': 'NCT04037904', 'briefTitle': 'Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication', 'orgStudyIdInfo': {'id': 'B-1509/316-302'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'H. pylori negative group', 'description': 'Subjects who have not have H. pylori infection, and had not receive H. pylori eradication'}, {'label': 'H. pylorieradicated group', 'description': 'Subjects who have had H. pylori infection currently and received successful H. pylori eradication according to appropriated indication'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nayoung Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}