Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-10 @ 12:56 PM
Study NCT ID:
NCT03218202
Status:
TERMINATED
Last Update Posted:
2019-09-03
First Post:
2017-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stricture Definition and Treatment (STRIDENT) Observational Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Standard blood tests. Tests for Single Nucleotide Polymorphisms. Stool testing, Tissue Sampling.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'To focus on STRIDENT intervention studies as this study population is heterogenous', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-29', 'studyFirstSubmitDate': '2017-07-07', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of symptoms', 'timeFrame': '12 months', 'description': 'Number of patients who develop symptoms and require step up in therapy (drug, endoscopic or surgical therapy).'}], 'secondaryOutcomes': [{'measure': 'Imaging features associated with development of symptoms (MRI).', 'timeFrame': '12 months', 'description': 'MaRIA'}, {'measure': 'Imaging features associated with development of symptoms (Intestinal Ultrasound).', 'timeFrame': '12 months', 'description': "Limberg's score"}, {'measure': 'Biochemical features associated with development of symptoms', 'timeFrame': '12 months', 'description': 'CRP and calprotectin'}, {'measure': 'Patient reported outcomes', 'timeFrame': '12 months', 'description': 'SF36'}, {'measure': 'Patient reported outcomes', 'timeFrame': '12 months', 'description': 'IBDQ'}, {'measure': 'Requirement for step up in drug therapy', 'timeFrame': '12 months', 'description': 'Need for additional drug therapy due to development of symptoms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', 'Crohn Disease', 'Ulcerative Colitis', 'Intestinal stricture'], 'conditions': ['Inflammatory Bowel Diseases', 'Crohn Disease', 'Ulcerative Colitis', 'Stricture; Colon']}, 'descriptionModule': {'briefSummary': "Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to determine biochemical and imaging features associated with the development of strictures and in related STRIDENT studies develop strategies for treatment.", 'detailedDescription': "Patients with asymptomatic Crohn's disease strictures will be followed prospectively for 12 months using imaging (including MRI/intestinal ultrasound) and biochemical analyses (including CRP/calprotectin). Patient's with symptomatic or asymptomatic ulcerative colitis related strictures will be followed similarly. Risk factors for progression of strictures and development of symptoms will be identified."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients with inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis) without symptoms who are incidentally found to have a stricture on CT, MRI or endoscopy.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy but without associated symptoms\n\nExclusion Criteria:\n\n* Low rectal or anal strictures\n* Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies\n* Patients for whom endoscopy is not suitable due to co-morbidities or clinical state\n* Inability to give informed consent\n* Suspected perforation of the gastrointestinal tract\n* Inability to undergo MRI small bowel due to a contraindication.'}, 'identificationModule': {'nctId': 'NCT03218202', 'acronym': 'STRIDENT', 'briefTitle': 'Stricture Definition and Treatment (STRIDENT) Observational Study.', 'organization': {'class': 'OTHER', 'fullName': "St Vincent's Hospital Melbourne"}, 'officialTitle': 'Stricture Definition and Treatment (STRIDENT) Observational Study.', 'orgStudyIdInfo': {'id': 'SVHMelbourneSTRIDENT3'}}, 'contactsLocationsModule': {'locations': [{'zip': '3065', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "St. Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Emily Wright, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital Melbourne"}, {'name': 'Bronte Holt, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital Melbourne"}, {'name': 'Michael Kamm, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital Melbourne"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St Vincent's Hospital Melbourne", 'class': 'OTHER'}, 'collaborators': [{'name': 'Australasian Gastro Intestinal Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Gastroenterology', 'investigatorFullName': 'Michael Kamm', 'investigatorAffiliation': "St Vincent's Hospital Melbourne"}}}}