Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:44 AM
Study NCT ID:
NCT04621006
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2020-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Contact Activation System and Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma (EDTA and citrate) stored at -70 degrees celcius. Fecal extract stored at -70 degrees celcius. Colonic tissue snap frozen with liquid nitrogen and stored at -70 degrees celcius.\n\nColonic tissue fixated in formalin and embeded in parafin within 72h.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical disease activity.', 'timeFrame': 'End of study (August 28th, 2024)', 'description': 'PRO2 score, 0-6 points. A score of one or more defines active disease.'}, {'measure': 'Endoscopic disease activity.', 'timeFrame': 'End of study (August 28th, 2024)', 'description': 'Mayo endoscopic score, 0-3 points. A score of one or more defines active disease.'}, {'measure': 'Kallikrein generation', 'timeFrame': 'End of study (August 28th, 2024)', 'description': 'The assay reflects the downstream activation of the contact activation system which allows us to determine the amount of kallikrein generated in each sample.'}, {'measure': 'Polymerised alpha-1-antitrypsin in participants', 'timeFrame': 'End of study (August 28th, 2024)', 'description': 'A Western blot verifies the present of polymerised alpha-1-antitrypsin.'}, {'measure': 'Polymerised alpha-1-antitrypsin as an activator of the contact activation system', 'timeFrame': 'End of study (August 28th, 2024)', 'description': 'We add polymerised alpha-1-antitrypsin to our kallikrein generation. If kallikrein is generated the polymers activated the system.'}, {'measure': 'Localisation of contact activation system components in tissue samples', 'timeFrame': 'End of study (August 28th, 2024)', 'description': 'Immunhistochemical methods locate FXII, PK, cHK (specific to plasma kallikrein and tissue kallikrein), C1 Inhibitor, and Kallistatin in biopsies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Misfolded protein', 'Coagulation Factor XII', 'Kallikrein', 'High Molecular Weight Kininogen', 'The contact activation system', 'Endoplasmatic reticulum stress', 'Misfolded alpha-1-antitrypsin', 'Inflammatory bowel disease', 'Inflammation'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The study aims to describe alterations in the contact activation system during active and inactive ulcerative colitis.\n\nContact activation system measures are compared in a cross sectional (healthy controls vs. active disease) and longitudinal (active diasese vs. inactive disease) fashion.', 'detailedDescription': 'We include and follow up on 102 adults with active ulcerative colitis. Visits are week 0 (inclusion), 6, 12 and 26 (end of study). We obtain plasma and fecal samples at each visit. Whereas we obtain colonic tissue samples only at inclusion and end of study.\n\nRegistered data are:\n\n* Demographics realate to UC and general wellbeing.\n* Clinical parametres used for UC evaluation are PRO2, SCCAI, CRP, fecal calprotectin, Mayo endoscopic subscore and Nancy index.\n* The contact activation system is characterised by FXII, prekallikrein, kallikrein generation, HK, cHK (specific to plasma kallikrein), cHK (specific to tissue kallikrein), C1 inhibitor and Kallistatin.\n* Polymerized alpha-1-antitrypsin is characterised by the degree of polymerization and the capacity to activate the contact activation system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are enrolled from the Department of Medical Gastroenterology at the Hospital of Southwest Jutland, Region of Southern Denmark, Denmark', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfill diagnostic criteria of ulcerative colitis\n* SCCAI score ≥ 5\n* Mayo Endoscopic Subscore ≥ 1\n* Age ≥ 18 years\n* Most understand written and oral information in Danish\n* Informed consent must be given\n\nExclusion Criteria:\n\n* Pregnancy\n* Infection at inclusion\n* Any existing disease at inclusion:\n\n * liver disease or defect in CAS\n * inflammatory rheumatologic or dermatologic disease\n * cardiovascular or renal disease\n * immunodeficiency or hematologic diseases\n * malignancies\n* Medication with\n\n * Systemic corticosteroids at inclusion\n * ACE-inhibitor\n * Acetylsalicylic acid/NSAID\n * Warfarin, Phenprocoumon, NOAC and heparins'}, 'identificationModule': {'nctId': 'NCT04621006', 'briefTitle': 'The Contact Activation System and Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Esbjerg Hospital - University Hospital of Southern Denmark'}, 'officialTitle': 'The Contact Activation System and Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'CAS UC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'UC group', 'description': 'Patients with active ulcerative colitis', 'interventionNames': ['Diagnostic Test: Continuously assessment of disease activity']}], 'interventions': [{'name': 'Continuously assessment of disease activity', 'type': 'DIAGNOSTIC_TEST', 'description': 'Continuous measures of disease activity and activity in the contact activation system.', 'armGroupLabels': ['UC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Department of Medical Gastroenterology, University Hospital of Southern Denmark', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}], 'overallOfficials': [{'name': 'Morten L Halling, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical Gastroenterology, University Hospital of Southern Denmark - Esbjerg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esbjerg Hospital - University Hospital of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'UMC Utrecht', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Morten Lee Halling', 'investigatorAffiliation': 'Esbjerg Hospital - University Hospital of Southern Denmark'}}}}