Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-05 @ 6:29 PM
Study NCT ID:
NCT04408703
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2020-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRognOstiC valuE of rEd Density in 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'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum albumin, faecal calprotectin, C-reactive protein, thrombocytosis and haemoglobin'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2020-05-25', 'studyFirstSubmitQcDate': '2020-05-25', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'correlation biomarker', 'timeFrame': 'week 52', 'description': 'Correlation between RD scores and fecal calprotectin, C-reactive protein (CRP), platelet count and haemoglobin at any point in the study.'}, {'measure': 'correlation histological score', 'timeFrame': 'week 52', 'description': 'Correlation between RD scores and Geboes histological score, the Nancy and the Robarts histological index at any point in the study.'}, {'measure': 'correlation endoscopic score', 'timeFrame': 'week 52', 'description': 'Correlation between RD scores and Mayo endoscopic subscore and UCEIS at any point in the study.'}], 'primaryOutcomes': [{'measure': 'sustained clinical remission', 'timeFrame': 'week 52', 'description': 'Number of patients with sustained clinical remission at week 52, defined as simple clinical colitis activity index (SCCAI) \\<3 AND no need for initiation of new treatment, escalation of therapy, UC related hospitalization or colectomy correlated to the RD score at baseline.'}], 'secondaryOutcomes': [{'measure': 'endoscopic remission Mayo', 'timeFrame': 'week 52', 'description': 'Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline.'}, {'measure': 'endoscopic remission UCEIS', 'timeFrame': 'week 52', 'description': 'Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopy', 'Artificial intelligence', 'Image analysis', 'Precision medicine', 'Inflammatory bowel disease'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '31915237', 'type': 'BACKGROUND', 'citation': 'Bossuyt P, Nakase H, Vermeire S, de Hertogh G, Eelbode T, Ferrante M, Hasegawa T, Willekens H, Ikemoto Y, Makino T, Bisschops R. Automatic, computer-aided determination of endoscopic and histological inflammation in patients with mild to moderate ulcerative colitis based on red density. Gut. 2020 Oct;69(10):1778-1786. doi: 10.1136/gutjnl-2019-320056. Epub 2020 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ulcerative colitis in clinical remission', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of UC for at least 3 months\n* Clinical remission with SCCAI \\<3 at baseline and stable remission for the last 3 months\n* Ability to give informed consent by the patient or legal representative in case of minority.\n\nExclusion Criteria:\n\n* Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid.\n* Uncontrolled coagulopathy.\n* Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy\n* Planned UC related surgery\n* Previous subtotal or total colectomy\n* Short bowel, ileostomy or colostomy\n* Pregnancy at baseline\n* Age younger than 16 years'}, 'identificationModule': {'nctId': 'NCT04408703', 'acronym': 'PROCEED-UC', 'briefTitle': 'PRognOstiC valuE of rEd Density in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'PRognOstiC valuE of rEd Density in Ulcerative Colitis: PROCEED-UC STUDY', 'orgStudyIdInfo': {'id': 's63012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ulcerative colitis in clinical remission', 'description': 'Clinical remission with SCCAI \\<3 at baseline and stable remission for the last 3 months', 'interventionNames': ['Diagnostic Test: Red Density']}], 'interventions': [{'name': 'Red Density', 'type': 'DIAGNOSTIC_TEST', 'description': 'Image analysis of endoscopic images in patients with ulcerative colitis', 'armGroupLabels': ['Ulcerative colitis in clinical remission']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda GI clinical research center', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Raf Bisschops, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}, {'name': 'Peter Bossuyt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sapporo Medical University', 'class': 'OTHER'}, {'name': 'Imelda GI Clinical Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}