Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-02-06 @ 9:50 AM
Study NCT ID:
NCT05420233
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2022-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The CROCO Study: CROhn's Disease COhort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2022-05-25', 'studyFirstSubmitQcDate': '2022-06-11', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lémann Index Y1', 'timeFrame': '1 year after diagnosis', 'description': 'The Lémann Index (LI) was developed to provide a tool to measure bowel damage in Crohn Disease (CD).\n\nDescriptive statistics will present quantitative variables as mean and standard deviation or median and interquartile range (depending on their distribution) and qualitative variables as count and percentage.\n\nTime to event endpoints (such as surgery and hospitalization) will be presented using cumulative incidence in a competing risk framework (with death without surgery as a competing event for time to surgery, for example). Cumulative incidence with its 95%CI will be estimated at meaningful timepoints and association between baseline predictors and time to event endpoint will be assessed using competing risks regression models. Correlation of LI and IBD-DI will be estimated, taking into account the repeated measurements.\n\nLémann Index is a continuous variable.'}, {'measure': 'Lémann Index Y3', 'timeFrame': '3 years after diagnosis', 'description': 'The Lémann Index (LI) was developed to provide a tool to measure bowel damage in Crohn Disease (CD).\n\nDescriptive statistics will present quantitative variables as mean and standard deviation or median and interquartile range (depending on their distribution) and qualitative variables as count and percentage.\n\nTime to event endpoints (such as surgery and hospitalization) will be presented using cumulative incidence in a competing risk framework (with death without surgery as a competing event for time to surgery, for example). Cumulative incidence with its 95%CI will be estimated at meaningful timepoints and association between baseline predictors and time to event endpoint will be assessed using competing risks regression models. Correlation of LI and IBD-DI will be estimated, taking into account the repeated measurements.\n\nLémann Index is a continuous variable.'}, {'measure': 'Lémann Index Y5', 'timeFrame': '5 years after diagnosis', 'description': 'The Lémann Index (LI) was developed to provide a tool to measure bowel damage in Crohn Disease (CD).\n\nDescriptive statistics will present quantitative variables as mean and standard deviation or median and interquartile range (depending on their distribution) and qualitative variables as count and percentage.\n\nTime to event endpoints (such as surgery and hospitalization) will be presented using cumulative incidence in a competing risk framework (with death without surgery as a competing event for time to surgery, for example). Cumulative incidence with its 95%CI will be estimated at meaningful timepoints and association between baseline predictors and time to event endpoint will be assessed using competing risks regression models. Correlation of LI and IBD-DI will be estimated, taking into account the repeated measurements.\n\nLémann Index is a continuous variable.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Crohn DII'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '40895198', 'type': 'DERIVED', 'citation': "Reves J, Buisson A, Burisch J, Arebi N, Ungaro R, Vieujean S, Cravo M, Ellul P, Duricova D, Sebastian S, Rodriguez-Lago I, Ordas I, Kaimakliotis I, Hernandez V, Mocanu I, Nachury M, Goldis A, Fumery M, Conceicao D, Pedersen NK, Guedes AF, Ribeiro R, Bigot N, Mary JY, Lambert J, Colombel JF, Torres J; CROCO Study Group. The CROCO (CROhn's Disease COhort Study) - study design and protocol. Therap Adv Gastroenterol. 2025 Aug 29;18:17562848251362594. doi: 10.1177/17562848251362594. eCollection 2025."}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to create a prospective Crohn Disease cohort, where patients receiving the most up-to-date therapies with a treat-to-target strategy, will be closely followed to characterize the progression of Crohn Disease by measuring the Lémann Index over time. The goal of the CROCO Study - "Crohn\'s Disease Cohort Study" is to promote a greater understanding of the long-term evolution of Crohn Disease , to describe prospectively the impact of different therapeutic strategies and develop accurate predictors of bowel disease damage and disability.', 'detailedDescription': 'Therefore, the investigators designed a prospective, multicentre, study of the clinical course, anatomical progression and treatment of newly diagnosed CD and plan to include 600 patients over a 2-year period. Patients will be followed over 5 years after diagnosis (the date of diagnosis will be the date of the index histopathology describing CD; in special situations where pathology is not available the date of diagnosis will be the date that CD was declared by the physician). A morphological evaluation (LI), using abdominal magnetic resonance, will be performed at 1, 3 and 5 years after diagnosis. Ileocolonoscopy, upper endoscopy and/or pelvic MRI will be included according to disease location. Patients will be treated with standard of care therapy and will be followed for 5 years after diagnosis, with semestrial visits after the Year 1 (LI 1). At each visit, clinical and laboratory markers will be collected. Perianal and abdominal surgeries during follow-up will be registered. The disability index questionnaire will also be recorded every year.\n\nA preliminary requisite is therefore to implement and standardize examination reports and damage definitions used to calculate the LI. To this end, training session, supervised by members of the steering committee, will be held for participating gastroenterologist and radiologists. Based on commented ileocolonoscopy, upper endoscopy abdominal MRI and pelvic MRI, these sessions will highlight how lesions should be characterized and graded accordingly to implement the Lémann Index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nTo be eligible all of the following criteria must be met:\n\n* Diagnosis of CD (according to ECCO guidelines) established within the past 12 months;\n* Patients able to understand the information provided to them and to give written informed consent for the study;\n* Male or female, age \\> 18 years.\n\nEXCLUSION CRITERIA:\n\n* Patients unwilling or unable to provide informed, written consent;\n* Severe underlying medical disorder with an anticipated life expectancy \\< 2 years;\n* Refusal or medical conditions (e.g. Glomerular filtration rate \\< 30 mL/min) preventing cross-sectional imaging during follow-up;\n* Uncertain CD diagnosis;\n* Pregnancy (if it is impossible to implement the MRE at one year) or any other reason that makes resonance not feasible throughout the study (eg claustrophobia).'}, 'identificationModule': {'nctId': 'NCT05420233', 'acronym': 'CROCO', 'briefTitle': "The CROCO Study: CROhn's Disease COhort Study", 'organization': {'class': 'OTHER', 'fullName': 'GLSMED Learning Health S.A.'}, 'officialTitle': "The CROCO Study: CROhn's Disease COhort Study", 'orgStudyIdInfo': {'id': 'The CROCO Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients diagnosed with Crohn´s disease within the past 12 months', 'description': 'All patients will undergo MRE in year 1, and this test may not be recommended in all patients. Year 1 MRE is the only procedure that may be performed outside of clinical practice.', 'interventionNames': ['Diagnostic Test: MRE']}], 'interventions': [{'name': 'MRE', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Magnetic Resonance Enterography'], 'description': 'Magnetic Resonance Enterography at year 1 (in some patients)', 'armGroupLabels': ['Patients diagnosed with Crohn´s disease within the past 12 months']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Liège', 'state': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sophie Vieujean', 'role': 'CONTACT'}], 'facility': 'University Hospital CHU of Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Stróvolos', 'status': 'RECRUITING', 'country': 'Cyprus', 'contacts': [{'name': 'Ioannis Kaimakliotis', 'role': 'CONTACT'}], 'facility': 'American Gastroenterology Center', 'geoPoint': {'lat': 35.14867, 'lon': 33.33384}}, {'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Dana Duricova', 'role': 'CONTACT'}], 'facility': 'IBD Clinical and Research Clinic, ISCARE', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Johan Burisch', 'role': 'CONTACT'}], 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Slagelse', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Natalia Pedersen', 'role': 'CONTACT'}], 'facility': 'Slagelse Hospital', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}, {'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathurin Fumery', 'role': 'CONTACT'}], 'facility': 'CHU Amiens-Picardie Hôpital Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anthony Buisson', 'role': 'CONTACT'}], 'facility': 'CHU Estaing Clermont - Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maria Nachury', 'role': 'CONTACT'}], 'facility': 'Claude Huriez Hospital, Lille University', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Padua', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Brigida Barberio', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'San Raffaele', 'status': 'WITHDRAWN', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.15407, 'lon': 7.86374}}, {'city': 'Msida', 'status': 'RECRUITING', 'country': 'Malta', 'contacts': [{'name': 'Pierre Elul', 'role': 'CONTACT'}], 'facility': 'Mater dei hospital', 'geoPoint': {'lat': 35.8925, 'lon': 14.48278}}, {'city': 'Almada', 'state': 'Almada', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Irina Mocanu', 'role': 'CONTACT'}], 'facility': 'Hospital Garcia da Orta', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'city': 'Lisbon', 'state': 'Lisbon District', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Daniel Conceição', 'role': 'CONTACT'}], 'facility': 'Instituto Portugues de Oncologia de Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Loures', 'state': 'Loures', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Joana Torres, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Beatriz Angelo', 'geoPoint': {'lat': 38.83091, 'lon': -9.16845}}, {'city': 'Timișoara', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Adrian Goldis', 'role': 'CONTACT'}], 'facility': 'Algomed Policlinic', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ingrid Ordas', 'role': 'CONTACT'}], 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Galdakao', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Iago Lago', 'role': 'CONTACT'}], 'facility': 'Hospital Galdakao-Usansolo', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'city': 'Vigo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vicent Hernandez', 'role': 'CONTACT'}], 'facility': 'Hospital Alvaro Cunqueiro - Área Sanitária de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Hull', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Shaji Sebastian', 'role': 'CONTACT'}], 'facility': 'Hull University Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Naila Arebi', 'role': 'CONTACT'}], 'facility': "St Mark's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Raquel C Ribeiro, Dr', 'role': 'CONTACT', 'email': 'croco.study@gmail.com', 'phone': '00351917483203'}, {'name': 'Rita C Eça, Dr', 'role': 'CONTACT', 'email': 'rheca@hospitaldaluz.pt'}], 'overallOfficials': [{'name': 'Joana T Torres, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luz Saude'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GLSMED Learning Health S.A.', 'class': 'OTHER'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}