Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:12 PM
Study NCT ID:
NCT07347834
Status:
RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRIOCOL - The Study of Continued Advanced Medical Therapy or Colectomy in Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2038-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HRQoL at six months', 'timeFrame': 'Primary endpoint evaluated six months after enrollement.', 'description': 'The patients will be evaluated with electronically distributed questionnaires at six months. The primary endpoint, health related quality of life (HRQOL), will be evaluated with 36-Item Short Form Survey (SF-36). Range 0-100. Higher number indicated better HRQOL.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative colitis', 'Advanced medical therapy', 'Colectomy', 'Health related quality of life', 'Shared decision-making'], 'conditions': ['Ulcerative Colitis (UC)']}, 'descriptionModule': {'briefSummary': 'Ulcerative colitis is an inflammatory disease affecting the rectum and colon, most commonly presenting in late adolescence or early adulthood. The primary treatment approach is pharmacological. Over the past two decades, there has been significant progress in the development of so-called advanced medical therapies, and new drugs in this category continue to emerge. These medications are highly effective for many patients, but not for all. If the first advanced therapy fails or is not tolerated, patients may switch to a second, third, or subsequent drugs. Unfortunately, the likelihood of success decreases with each additional line of therapy.\n\nAn alternative is surgery, specifically colectomy, which is a potentially curative treatment but may have a major impact on the individual. The overall objective of the study is to evaluate quality of life, functional outcomes, and patient satisfaction among those who choose continued medical therapy, compared to those who undergo colectomy, after at least two failed advanced medical therapies. Before making their treatment decision and enrolling in the study, patients will receive standardized information about all treatment options from a gastroenterologist and a colorectal surgeon. The aim is that the results of this study will provide valuable insights to better guide future patients with ulcerative colitis in choosing between continued advanced medical therapy and surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of all adult patients (≥18 years) with UC with active disease, at any of the participating centres, who have failed at least two lines of AMTs, and are eligible for both continued AMT and colectomy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with UC with active disease\n* failed at least two lines of advanced medical therapies\n* are eligible for both continued AMT and colectomy\n\nExclusion Criteria:\n\n* diagnostic uncertainty\n* diagnosis of impaired cognitive function\n* non-domestic and non-English speaking'}, 'identificationModule': {'nctId': 'NCT07347834', 'acronym': 'TRIOCOL', 'briefTitle': 'TRIOCOL - The Study of Continued Advanced Medical Therapy or Colectomy in Patients With Ulcerative Colitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'TRIOCOL - The Study of Continued Advanced Medical Therapy or Colectomy in Patients With Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'KI 4-3290/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Contunued advanced medical therapy', 'description': 'If the patient chooses continued medical therapy, the gastroenterologist evaluates the patient for a new line of AMT in accordance with clinical practice. The study period starts on the date of initiation of the new drug.'}, {'label': 'Colectomy', 'description': 'If the patient chooses colectomy the surgeon will inform the patient further, schedule the surgery, and if needed commence with preoperative optimization in accordance with standard clinical practice. The study period starts at the date of surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Solna', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Carl Kördel, MD, PhD-student', 'role': 'CONTACT', 'email': 'carl.kordel@ki.se', 'phone': '+46702545871'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}], 'centralContacts': [{'name': 'Carl Kördel, MD, PhD-student', 'role': 'CONTACT', 'email': 'carl.kordel@ki.se', 'phone': '+46702545871'}], 'overallOfficials': [{'name': 'Caroline Nordenvall, Ass. professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Legal agreements will be set up between all sites that will contribute data to the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}