[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508641":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":23,"studyPopulation":24,"armGroups":19,"interventions":25,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":303,"collaborators":19,"id":305,"slug":19,"hasResults":306,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":306,"sex":312,"minAge":313,"maxAge":314,"enrollmentInfo":315,"targetDuration":19,"studyType":318,"phases":19,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":65,"whyStopped":19,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},{"fullName":5,"class":6},"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD","An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models.","Day 1",[14,17],{"measure":15,"description":16,"timeFrame":12},"Intra- and inter-observer variability of lesions observed per segment during MRE in CD","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":18,"description":16,"timeFrame":12},"Intra- and inter-observer variability of depth and grade of global transmural healing in CD",null,{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":21,"timePerspective":22,"maskingInfo":19},"COHORT","PROSPECTIVE","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.","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",[26],{"type":27,"name":28,"description":29,"armGroupLabels":19,"otherNames":19},"PROCEDURE","Magnetic Resonance Enterography (MRE)","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.",[31],{"name":32,"affiliation":33,"role":34},"Sophie GEYL","CHU Limoge Dupuytren","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":19,"email":39},"CONTACT","+33 5 55 05 66 31","sophie.geyl@chu-limoges.fr",{"name":41,"role":37,"phone":42,"phoneExt":19,"email":43},"Laurent PEYRIN-BIROULET","+33 3 83 15 36 61","peyrinbiroulet@gmail.com",[45,63,80,94,108,122,136,150,163,177,191,205,219,233,247,261,275,289],{"facility":46,"status":47,"city":48,"state":19,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"CHU de Liège","NOT_YET_RECRUITING","Liège","4000","Belgium","BE",{"type":53,"coordinates":54},"Point",[55,56],5.56749,50.63373,{"lat":56,"lon":55},[59,62],{"name":60,"role":37,"phone":19,"phoneExt":19,"email":61},"Catherine Reenaers","Catherine.Reenaers@chuliege.be",{"name":60,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":64,"status":65,"city":66,"state":19,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"CHU Amiens-Picardie (site Sud)","RECRUITING","Amiens","80054","France","FR",{"type":53,"coordinates":71},[72,73],2.3,49.9,{"lat":73,"lon":72},[76,79],{"name":77,"role":37,"phone":19,"phoneExt":19,"email":78},"Mathurin Fumery","fumery.mathurin@chu-amiens.fr",{"name":77,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":81,"status":47,"city":82,"state":19,"zip":83,"country":68,"countryCode":69,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"CHU de Bordeaux - Hôpital Haut-Lévêque","Bordeaux","33600",{"type":53,"coordinates":85},[86,87],-0.58046,44.84124,{"lat":87,"lon":86},[90,93],{"name":91,"role":37,"phone":19,"phoneExt":19,"email":92},"David Laharie","david.laharie@chu-bordeaux.fr",{"name":91,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":95,"status":47,"city":96,"state":19,"zip":97,"country":68,"countryCode":69,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"APHP - Hôpital Ambroise Paré","Boulogne-Billancourt","92100",{"type":53,"coordinates":99},[100,101],2.24128,48.83545,{"lat":101,"lon":100},[104,107],{"name":105,"role":37,"phone":19,"phoneExt":19,"email":106},"Thomas Bazin","thomas.bazin@aphp.fr",{"name":105,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":109,"status":65,"city":110,"state":19,"zip":111,"country":68,"countryCode":69,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"CHU de Clermont-Ferrand - Hôpital d'Estaing","Clermont-Ferrand","63003",{"type":53,"coordinates":113},[114,115],3.08682,45.77969,{"lat":115,"lon":114},[118,121],{"name":119,"role":37,"phone":19,"phoneExt":19,"email":120},"Anthony Buisson","a_buisson@chu-clermontferrand.fr",{"name":119,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":123,"status":47,"city":124,"state":19,"zip":125,"country":68,"countryCode":69,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"APHP - Hôpital Louis Mourier","Colombes","92700",{"type":53,"coordinates":127},[128,129],2.25404,48.91882,{"lat":129,"lon":128},[132,135],{"name":133,"role":37,"phone":19,"phoneExt":19,"email":134},"Benoît Coffin","benoit.coffin@aphp.fr",{"name":133,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":137,"status":47,"city":138,"state":19,"zip":139,"country":68,"countryCode":69,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"CHRU de Lille - Hôpital Claude Huriez","Lille","59037",{"type":53,"coordinates":141},[142,143],3.05512,50.63391,{"lat":143,"lon":142},[146,149],{"name":147,"role":37,"phone":19,"phoneExt":19,"email":148},"Sofia Hambli","sofia.hambli@chru-lille.fr",{"name":147,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":151,"status":65,"city":152,"state":19,"zip":153,"country":68,"countryCode":69,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"CHU Limoges Dupuytren","Limoges","87000",{"type":53,"coordinates":155},[156,157],1.24759,45.83362,{"lat":157,"lon":156},[160,162],{"name":161,"role":37,"phone":19,"phoneExt":19,"email":39},"Sophie Geyl",{"name":161,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":164,"status":47,"city":165,"state":19,"zip":166,"country":68,"countryCode":69,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"AP-HM - Hôpital Nord","Marseille","13015",{"type":53,"coordinates":168},[169,170],5.38107,43.29695,{"lat":170,"lon":169},[173,176],{"name":174,"role":37,"phone":19,"phoneExt":19,"email":175},"Mélanie Serrero","melanie.serrero@ap-hm.fr",{"name":174,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":178,"status":65,"city":179,"state":19,"zip":180,"country":68,"countryCode":69,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"CHU de Montpellier - Hôpital Saint Eloi","Montpellier","34295",{"type":53,"coordinates":182},[183,184],3.87635,43.61093,{"lat":184,"lon":183},[187,190],{"name":188,"role":37,"phone":19,"phoneExt":19,"email":189},"Romain Altwegg","r-altwegg@chu-montpellier.fr",{"name":188,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":192,"status":47,"city":193,"state":19,"zip":194,"country":68,"countryCode":69,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"CHU de Nantes","Nantes","44093",{"type":53,"coordinates":196},[197,198],-1.55336,47.21725,{"lat":198,"lon":197},[201,204],{"name":202,"role":37,"phone":19,"phoneExt":19,"email":203},"Catherine Le Berre","catherine@leberre.org",{"name":202,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":206,"status":47,"city":207,"state":19,"zip":208,"country":68,"countryCode":69,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"CHU de Nice - Hôpital l'Archet II","Nice","06200",{"type":53,"coordinates":210},[211,212],7.26608,43.70313,{"lat":212,"lon":211},[215,218],{"name":216,"role":37,"phone":19,"phoneExt":19,"email":217},"Xavier Hébuterne","hebuterne.x@chu-nice.fr",{"name":216,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":220,"status":47,"city":221,"state":19,"zip":222,"country":68,"countryCode":69,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"CHU de Nîmes - Hôpital Carémeau","Nîmes","30029",{"type":53,"coordinates":224},[225,226],4.35788,43.83665,{"lat":226,"lon":225},[229,232],{"name":230,"role":37,"phone":19,"phoneExt":19,"email":231},"Ludovic Caillo","ludovic.caillo@chu-nimes.fr",{"name":230,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":234,"status":47,"city":235,"state":19,"zip":236,"country":68,"countryCode":69,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"APHP - Hôpital Européen Georges Pompidou (HEGP)","Paris","75908",{"type":53,"coordinates":238},[239,240],2.3488,48.85341,{"lat":240,"lon":239},[243,246],{"name":244,"role":37,"phone":19,"phoneExt":19,"email":245},"Mathilde Wisniewski","mathilde.wisniewski@aphp.fr",{"name":244,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":248,"status":47,"city":249,"state":19,"zip":250,"country":68,"countryCode":69,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Hospices Civils de Lyon","Pierre-Bénite","69475",{"type":53,"coordinates":252},[253,254],4.82424,45.70359,{"lat":254,"lon":253},[257,260],{"name":258,"role":37,"phone":19,"phoneExt":19,"email":259},"Stéphane Nancey","stephane.nancey@chu-lyon.fr",{"name":258,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":262,"status":47,"city":263,"state":19,"zip":264,"country":68,"countryCode":69,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"CHU Rennes - Hôpital Pontchaillou","Rennes","35033",{"type":53,"coordinates":266},[267,268],-1.67431,48.11109,{"lat":268,"lon":267},[271,274],{"name":272,"role":37,"phone":19,"phoneExt":19,"email":273},"Guillaume Bouguen","guillaume.bouguen@chu-rennes.fr",{"name":272,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":276,"status":47,"city":277,"state":19,"zip":278,"country":68,"countryCode":69,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"CHU de Saint Etienne - Hôpital Nord","Saint-Priest-en-Jarez","42270",{"type":53,"coordinates":280},[281,282],4.37678,45.4739,{"lat":282,"lon":281},[285,288],{"name":286,"role":37,"phone":19,"phoneExt":19,"email":287},"Xavier Roblin","xavier.roblin@chu-st-etienne.fr",{"name":286,"role":34,"phone":19,"phoneExt":19,"email":19},{"facility":290,"status":47,"city":291,"state":19,"zip":292,"country":68,"countryCode":69,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"CHRU de Nancy - Hôpitaux de Brabois","Vandœuvre-lès-Nancy","54500",{"type":53,"coordinates":294},[295,296],6.17114,48.66115,{"lat":296,"lon":295},[299,302],{"name":300,"role":37,"phone":19,"phoneExt":19,"email":301},"Laurent Peyrin-Biroulet","l.peyrin-biroulet@chru-nancy.fr",{"name":300,"role":34,"phone":19,"phoneExt":19,"email":19},{"type":304,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100508641",false,"NCT05903066","TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)","TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study","TRENCH 1","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","ALL","18 Years","75 Years",{"count":316,"type":317},210,"ESTIMATED","OBSERVATIONAL","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",[321],"Crohn Disease",[323,324],"IBD","CD","2024-10-04",{"date":327,"type":328},"2024-10-08","ACTUAL",{"date":330,"type":328},"2023-09-28",{"date":332,"type":317},"2025-08",{"name":5,"class":6},18]