Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT03288961
Status:
UNKNOWN
Last Update Posted:
2019-08-13
First Post:
2017-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self Screening Tool for Crohn's Perianal Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-09-19', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perianal fistula', 'timeFrame': '1 day', 'description': 'perianal fistula rate confirmed by MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "This study aims to develop a self-screening tool for Crohn's perianal fistula."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Crohn's disease patients are asked to fill out survey of their perianal symptoms. Survey score is compared with MRI results as the gold standard.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Crohn's disease\n\nExclusion Criteria:\n\n\\-"}, 'identificationModule': {'nctId': 'NCT03288961', 'briefTitle': "Self Screening Tool for Crohn's Perianal Fistula", 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Hospital'}, 'officialTitle': "Development and Validation of Patient Self-screening and Monitoring Tool for Crohn's Perianal Fistula", 'orgStudyIdInfo': {'id': 'KNUH14'}}, 'contactsLocationsModule': {'locations': [{'zip': '41944', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun Soo Kim, MD, PhD', 'role': 'CONTACT', 'email': 'dandy813@hanmail.net', 'phone': '+82-53-250-5879'}], 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Eun Soo Kim, MD, PhD', 'investigatorAffiliation': 'Kyungpook National University Hospital'}}}}