Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-03 @ 3:33 AM
Study NCT ID:
NCT06485193
Status:
TERMINATED
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Innate Immune Response and Enteric Nervous System in Crohn's Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-12-06', 'releaseDate': '2024-10-19'}], 'estimatedResultsFirstSubmitDate': '2024-10-19'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Preliminary results showed no signs of associations in the data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MxA expression', 'timeFrame': 'June 1 2024', 'description': 'Immunohistochemical Mxa expression'}], 'secondaryOutcomes': [{'measure': 'Enterovirus positivity', 'timeFrame': 'June 1 2024', 'description': 'pan-enterovirus immunohistochemistry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "The study aims to explore the relationships between inflammation, nerve changes, and the expression of interferon-stimulated proteins in inflamed and non-inflamed bowel areas from patients with Crohn's disease. Crohn's disease is a chronic inflammatory condition with complex causes and mechanisms that remain uncertain despite extensive research.\n\nMethods and Procedures This exploratory study utilizes tissue samples from a clinical biobank at Aalborg University Hospital. The samples are paraffin-embedded blocks from which tissue sections are prepared for immunohistochemical and histological staining. The study focuses on assessing the expression of interferon-stimulated proteins through optimized immunohistochemical staining methods, ensuring reproducibility via automated machines. The protein expressions are then analyzed qualitatively and semi-quantitatively and compared with structural changes in the bowel tissues."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Crohn's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histological preparations (tissue samples) from patients with Crohn's disease who have undergone bowel resection at Aalborg University Hospital in the period from 2012 to 2023.\n\nExclusion Criteria:\n\n* If the tissue material does not include the ileocecal region.\n* If the pathology report does not indicate that there is tissue material from both inflamed and non-inflamed areas.\n* If the patient has registered a prohibition against research in the Tissue Utilization Registry.\n* The selection of cases starts with the most recent (by date) and stops when 25 suitable cases are found."}, 'identificationModule': {'nctId': 'NCT06485193', 'briefTitle': "The Innate Immune Response and Enteric Nervous System in Crohn's Disease.", 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Det medfødte Immunforsvar og Det Enteriske Nervesystem Ved Crohns Sygdom', 'orgStudyIdInfo': {'id': 'N-20230024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immunohistochemistry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Immunohistochemical analysis of archived diagnostic tissue samples.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'Northern Region', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Christian Thomsen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-10-19', 'type': 'RELEASE'}, {'date': '2024-12-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Christian Thomsen, Principal Investigator, Aalborg University Hospital'}}}}