Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-27 @ 6:35 AM
Study NCT ID:
NCT03523559
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2018-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic and Histopathologic Characteristics of Interstitial Cystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-25', 'studyFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genetic differences between ulcer and non-ulcer of bladder in Interstitial Cystitis', 'timeFrame': '30days'}, {'measure': 'Genetic differences between bladder tissue of Interstitial Cystitis and normal bladder tissue', 'timeFrame': '30days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Cystitis']}, 'descriptionModule': {'briefSummary': 'Genetic and Histopathologic Characteristics of Interstitial Cystitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Patients diagnosed with Hunner lesion in Interstitial cystitis and who is scheduled to undergo transurethral resection\n* Patients diagnosed with Bladder cancer and who is scheduled to undergo cystectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female aged 19 yrs or greater\n* Patients diagnosed with Hunner lesion in Interstitial cystitis and who is scheduled to undergo transurethral resection\n* Patients diagnosed with Bladder cancer and who is scheduled to undergo cystectomy\n\nExclusion Criteria:\n\n* Male and female under aged 20 yrs\n* A person whose area of bladder cancer is larger than that of the normal area\n* A person who is going to have a cystectomy after chemotherapy on bladder cancer'}, 'identificationModule': {'nctId': 'NCT03523559', 'briefTitle': 'Genetic and Histopathologic Characteristics of Interstitial Cystitis', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Genetic and Histopathologic Characteristics of Interstitial Cystitis', 'orgStudyIdInfo': {'id': '2018-03-025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interstitial Cystitis', 'interventionNames': ['Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue']}, {'label': 'normal', 'interventionNames': ['Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue']}], 'interventions': [{'name': 'bladder tissue of Interstitial Cystitis and normal bladder tissue', 'type': 'GENETIC', 'description': 'Obtain the bladder tissue of Interstitial Cystitis and normal during the operation', 'armGroupLabels': ['Interstitial Cystitis', 'normal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'KYU-SUNG LEE', 'investigatorAffiliation': 'Samsung Medical Center'}}}}