Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-01-04 @ 10:41 AM
Study NCT ID:
NCT05903066
Status:
RECRUITING
Last Update Posted:
2024-10-08
First Post:
2023-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood serum, stool.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-04', 'studyFirstSubmitDate': '2023-06-05', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD', 'timeFrame': 'Day 1', 'description': 'An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models.'}], 'secondaryOutcomes': [{'measure': 'Intra- and inter-observer variability of lesions observed per segment during MRE in CD', 'timeFrame': 'Day 1', 'description': 'Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.'}, {'measure': 'Intra- and inter-observer variability of depth and grade of global transmural healing in CD', 'timeFrame': 'Day 1', 'description': 'Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD', 'CD'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD).\n\nPrimary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD", 'detailedDescription': 'Number of patients : 210 patients, in 14 sites (only one investigator per site), 15 patients per site, 5 patients per grade of transmural healing based on the appraisal of a local reader pair (a gastroenterologist and a radiologist).\n\nRecruitment period : 2 years\n\nPrimary Endpoint : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD\n\nSecondary Endpoints :\n\n* To analyze intra- and inter-observer variability of radiological findings.\n* To analyze intra- and inter-observer variability of TH definitions in CD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with CD for more than 6 months with histological confirmation available in his medical record, with an indication for MRE based on routine clinical practice validated by the treating physician', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record.\n* Indication for MRE based on routine clinical practice validated by the treating physician\n* Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate…).\n* The subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study.\n* A subject can be enrolled into the study only if the grade of TH (assessed by the LRP) corresponding to the subject is not already fulfilled.\n\nExclusion Criteria:\n\n* Pregnancy during the study\n* People unable to give consent (because of their physical or mental state)\n* Absence of written consent\n* Ulcerative colitis or unclassified IBD\n* Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy.\n* Less than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve)\n* Severe obstructive symptoms\n* Symptomatic intra-abdominal abscess\n* Contraindication for MRI\n* Isolated perianal disease without luminal location\n* MRE images of poor quality, based on previously defined criteria'}, 'identificationModule': {'nctId': 'NCT05903066', 'acronym': 'TRENCH 1', 'briefTitle': "TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)", 'organization': {'class': 'OTHER', 'fullName': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives"}, 'officialTitle': "TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study", 'orgStudyIdInfo': {'id': 'GETAID-2022-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic Resonance Enterography (MRE)', 'type': 'PROCEDURE', 'description': 'MRE performed as part of the standard of care follow up of the patient, the exam will be recorded for the study and analysed by central readers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Catherine Reenaers', 'role': 'CONTACT', 'email': 'Catherine.Reenaers@chuliege.be'}, {'name': 'Catherine Reenaers', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathurin Fumery', 'role': 'CONTACT', 'email': 'fumery.mathurin@chu-amiens.fr'}, {'name': 'Mathurin Fumery', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Amiens-Picardie (site Sud)', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '33600', 'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'David Laharie', 'role': 'CONTACT', 'email': 'david.laharie@chu-bordeaux.fr'}, {'name': 'David Laharie', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux - Hôpital Haut-Lévêque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas Bazin', 'role': 'CONTACT', 'email': 'thomas.bazin@aphp.fr'}, {'name': 'Thomas Bazin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP - Hôpital Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anthony Buisson', 'role': 'CONTACT', 'email': 'a_buisson@chu-clermontferrand.fr'}, {'name': 'Anthony Buisson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHU de Clermont-Ferrand - Hôpital d'Estaing", 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92700', 'city': 'Colombes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoît Coffin', 'role': 'CONTACT', 'email': 'benoit.coffin@aphp.fr'}, {'name': 'Benoît Coffin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP - Hôpital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '59037', 'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sofia Hambli', 'role': 'CONTACT', 'email': 'sofia.hambli@chru-lille.fr'}, {'name': 'Sofia Hambli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU de Lille - Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87000', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Geyl', 'role': 'CONTACT', 'email': 'sophie.geyl@chu-limoges.fr'}, {'name': 'Sophie Geyl', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Limoges Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13015', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mélanie Serrero', 'role': 'CONTACT', 'email': 'melanie.serrero@ap-hm.fr'}, {'name': 'Mélanie Serrero', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HM - Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain Altwegg', 'role': 'CONTACT', 'email': 'r-altwegg@chu-montpellier.fr'}, {'name': 'Romain Altwegg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Montpellier - Hôpital Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine Le Berre', 'role': 'CONTACT', 'email': 'catherine@leberre.org'}, {'name': 'Catherine Le Berre', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06200', 'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Hébuterne', 'role': 'CONTACT', 'email': 'hebuterne.x@chu-nice.fr'}, {'name': 'Xavier Hébuterne', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHU de Nice - Hôpital l'Archet II", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ludovic Caillo', 'role': 'CONTACT', 'email': 'ludovic.caillo@chu-nimes.fr'}, {'name': 'Ludovic Caillo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nîmes - Hôpital Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75908', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathilde Wisniewski', 'role': 'CONTACT', 'email': 'mathilde.wisniewski@aphp.fr'}, {'name': 'Mathilde Wisniewski', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP - Hôpital Européen Georges Pompidou (HEGP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69475', 'city': 'Pierre-Bénite', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane Nancey', 'role': 'CONTACT', 'email': 'stephane.nancey@chu-lyon.fr'}, {'name': 'Stéphane Nancey', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '35033', 'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Bouguen', 'role': 'CONTACT', 'email': 'guillaume.bouguen@chu-rennes.fr'}, {'name': 'Guillaume Bouguen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Rennes - Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Roblin', 'role': 'CONTACT', 'email': 'xavier.roblin@chu-st-etienne.fr'}, {'name': 'Xavier Roblin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Saint Etienne - Hôpital Nord', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Peyrin-Biroulet', 'role': 'CONTACT', 'email': 'l.peyrin-biroulet@chru-nancy.fr'}, {'name': 'Laurent Peyrin-Biroulet', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU de Nancy - Hôpitaux de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Sophie GEYL', 'role': 'CONTACT', 'email': 'sophie.geyl@chu-limoges.fr', 'phone': '+33 5 55 05 66 31'}, {'name': 'Laurent PEYRIN-BIROULET', 'role': 'CONTACT', 'email': 'peyrinbiroulet@gmail.com', 'phone': '+33 3 83 15 36 61'}], 'overallOfficials': [{'name': 'Sophie GEYL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Limoge Dupuytren'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}