[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449999":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":39,"studyPopulation":40,"armGroups":41,"interventions":59,"overallOfficials":65,"centralContacts":70,"locations":78,"responsibleParty":266,"collaborators":35,"id":268,"slug":35,"hasResults":269,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":274,"sex":275,"minAge":276,"maxAge":35,"enrollmentInfo":277,"targetDuration":35,"studyType":280,"phases":35,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":220,"whyStopped":35,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},{"fullName":5,"class":6},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups.","As measured by flow cytometry and sequencing techniques, with a sample size sufficient to attain a 92% statistical power and 5% alpha risk.\n\nFrequency will be expressed as number of antigen-reactive T lymphocytes per 100,000 total T lymphocytes (e.g. 20\u002F100,000 or 0.02%).\n\nPhenotype will be expressed as percent of antigen-reactive T lymphocytes expressing a given phenotype, e.g. 20% naïve (CD45RA+CCR7+).\n\nThese 2 measures will be aggregated by expressing the frequency of antigen-reactive T lymphocytes per 100,000 total T lymphocytes expressing a given phenotype, e.g. 20\u002F100,000 antigen-reactive T lymphocytes with 20% naïve will be expressed as 4\u002F100,000 naive antigen-reactive T lymphocytes.","6 years",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"To define the frequency and phenotype of autoimmune B lymphocytes reactive to islet antigens in the different study groups.","As measured by flow cytometry and sequencing techniques, with a sample size sufficient to attain a 92% statistical power and 5% alpha risk.\n\nFrequency will be expressed as number of antigen-reactive B lymphocytes per 100,000 total B lymphocytes (e.g. 20\u002F100,000 or 0.02%).\n\nPhenotype will be expressed as percent of antigen-reactive B lymphocytes expressing a given phenotype, e.g. 20% memory (CD24+CD38-negative).\n\nThese 2 measures will be aggregated by expressing the frequency of antigen-reactive B lymphocytes per 100,000 total B lymphocytes expressing a given phenotype, e.g. 20\u002F100,000 antigen-reactive B lymphocytes with 20% memory will be expressed as 4\u002F100,000 memory antigen-reactive B lymphocytes.",{"measure":18,"description":19,"timeFrame":12},"To identify novel islet epitopes recognized by autoimmune T and B lymphocytes.","As measured by a lymphocyte frequency within the expected range, e.g. 1-50\u002Fmillion.",{"measure":21,"description":22,"timeFrame":12},"To define the phenotype of these lymphocytes.","As defined by exploratory analyses based on omics techniques.",{"measure":24,"description":25,"timeFrame":12},"To define the pathogenicity of these lymphocytes against pancreatic beta cells.","As measured by an in vitro killing of beta-cell targets significantly (e.g. \\>2-fold) higher than the killing observed with control lymphocytes.",{"measure":27,"description":28,"timeFrame":12},"To define the antigen receptors used by these lymphocytes to recognize their target epitopes.","As defined by sequencing techniques and sequence annotation using IMGT and MiXCR. Sequence sharing and similarities across receptors will be measured using MiXCR and stringdist.",{"measure":30,"description":31,"timeFrame":12},"To define the correlation between the biomarkers analyzed and insulin secretion.","As measured based on the correlation with fasting C-peptide levels \\>0.2 nM.",{"measure":33,"description":34,"timeFrame":12},"To define the differences between lymphocytes in the blood and those in pancreatic lymph nodes.","As measured using the previous frequency and phenotype readouts.",null,{"allocation":35,"interventionModel":35,"interventionModelDescription":35,"primaryPurpose":35,"observationalModel":37,"timePerspective":38,"maskingInfo":35},"CASE_CONTROL","PROSPECTIVE","The overall objective of this study is to define the differential characteristics of autoimmune T and B lymphocytes across individuals with T1D, other forms of diabetes or autoimmunity, and no disease. The hypothesis is that the characterization of the autoimmune T and B lymphocytes involved in T1D development may allow us to clarify the pathophysiological mechanisms of disease and to identify novel biomarkers for diagnostic, prognostic and therapeutic follow-up applications.","Participants with type 1 diabetes, other forms of diabetes or autoimmune endocrinopathies and participants undergoing surgical lymphadenectomy are recruited among patients referred to participating hospital centers.\n\nNon-diabetic participants are recruited among patient's family members and via at-large calls for healthy volunteers.",[42,47,51,55],{"label":43,"type":35,"description":44,"interventionNames":45},"Type 1 diabetes","As defined by the presence of hyperglycemia and\u002For islet auto-antibodies.",[46],"Other: Biosampling",{"label":48,"type":35,"description":49,"interventionNames":50},"Other forms of diabetes or autoimmune endocrinopathy","Type 2 diabetes, ketosis-prone diabetes, familial diabetes, secondary diabetes, immunotherapy-induced diabetes; and\u002For autoimmune endocrinopathies.",[46],{"label":52,"type":35,"description":53,"interventionNames":54},"No diabetes","No diabetes or impaired glucose tolerance; no cancer, infectious or immune pathologies; no other condition related to autoimmune and metabolic alterations that may bias the variables under study.",[46],{"label":56,"type":35,"description":57,"interventionNames":58},"Lymphadenectomy planned at the occasion of an abdominal surgery","Patients undergoing a lymphadenectomy during surgery for the treatment of their underlying pathology.",[46],[60],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":35},"OTHER","Biosampling","Collection of blood and stool specimens; and collection of lymph node specimens for the group undergoing surgical lymphadenectomy.",[56,52,48,43],[66],{"name":67,"affiliation":68,"role":69},"Roberto Mallone, MD PhD","INSERM U1016 Cochin Institute","PRINCIPAL_INVESTIGATOR",[71,75],{"name":67,"role":72,"phone":73,"phoneExt":35,"email":74},"CONTACT","+33176535583","roberto.mallone@inserm.fr",{"name":76,"role":72,"phone":35,"phoneExt":35,"email":77},"Anna Jones","anna.jones@inserm.fr",[79,96,111,123,135,147,155,167,181,190,199,209,218,227,236,245,254],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"APHP Hôpital Avicenne","NOT_YET_RECRUITING","Bobigny","Île-de-France Region","93000","France","FR",{"type":88,"coordinates":89},"Point",[90,91],2.45012,48.90982,{"lat":91,"lon":90},[94],{"name":95,"role":72,"phone":35,"phoneExt":35,"email":35},"Emmanuel Cosson, MD PhD",{"facility":97,"status":81,"city":98,"state":83,"zip":99,"country":85,"countryCode":86,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"APHP Hôpital J. Verdier","Bondy","93140",{"type":88,"coordinates":101},[102,103],2.48931,48.9018,{"lat":103,"lon":102},[106,108],{"name":107,"role":72,"phone":35,"phoneExt":35,"email":35},"Nadine Lucidarme, MD",{"name":109,"role":110,"phone":35,"phoneExt":35,"email":35},"Auriane Gibert, MD","SUB_INVESTIGATOR",{"facility":112,"status":81,"city":113,"state":83,"zip":114,"country":85,"countryCode":86,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"APHP Hôpital L. Mourier","Colombes","92700",{"type":88,"coordinates":116},[117,118],2.25404,48.91882,{"lat":118,"lon":117},[121],{"name":122,"role":72,"phone":35,"phoneExt":35,"email":35},"Stéphanie Gréteau-Hamoumou, MD",{"facility":124,"status":81,"city":125,"state":83,"zip":126,"country":85,"countryCode":86,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Hôpital Sud Francilien","Corbeil-Essonnes","91100",{"type":88,"coordinates":128},[129,130],2.48757,48.60603,{"lat":130,"lon":129},[133],{"name":134,"role":72,"phone":35,"phoneExt":35,"email":35},"Alfred Penfornis, MD PhD",{"facility":136,"status":81,"city":137,"state":83,"zip":138,"country":85,"countryCode":86,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Hôpital Mignot - Service de Pédiatrie","Le Chesnay","78150",{"type":88,"coordinates":140},[141,142],2.12213,48.8222,{"lat":142,"lon":141},[145],{"name":146,"role":72,"phone":35,"phoneExt":35,"email":35},"Catherine Ajzenman, MD",{"facility":148,"status":81,"city":137,"state":83,"zip":138,"country":85,"countryCode":86,"cosmosGeoPoint":149,"geoPoint":151,"contacts":152},"Hôpital Mignot - Services de Diabétologie\u002FEndocrinologie Adultes",{"type":88,"coordinates":150},[141,142],{"lat":142,"lon":141},[153],{"name":154,"role":72,"phone":35,"phoneExt":35,"email":35},"Jean-Paul Beressi, MD",{"facility":156,"status":81,"city":157,"state":83,"zip":158,"country":85,"countryCode":86,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"APHP Hôpital Kremlin-Bicêtre","Le Kremlin-Bicêtre","94270",{"type":88,"coordinates":160},[161,162],2.36073,48.81471,{"lat":162,"lon":161},[165],{"name":166,"role":72,"phone":35,"phoneExt":35,"email":35},"Cécile Petit-Bibal, MD",{"facility":168,"status":81,"city":169,"state":83,"zip":170,"country":85,"countryCode":86,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"APHP Hôpital Lariboisière","Paris","75010",{"type":88,"coordinates":172},[173,174],2.3488,48.85341,{"lat":174,"lon":173},[177,179],{"name":178,"role":72,"phone":35,"phoneExt":35,"email":35},"Jean-François Gautier, MD PhD",{"name":180,"role":110,"phone":35,"phoneExt":35,"email":35},"Jean-Pierre Riveline, MD PhD",{"facility":182,"status":81,"city":169,"state":83,"zip":183,"country":85,"countryCode":86,"cosmosGeoPoint":184,"geoPoint":186,"contacts":187},"APHP Hôpital Saint Antoine","75012",{"type":88,"coordinates":185},[173,174],{"lat":174,"lon":173},[188],{"name":189,"role":72,"phone":35,"phoneExt":35,"email":35},"Bruno Fève, MD PhD",{"facility":191,"status":81,"city":169,"state":83,"zip":192,"country":85,"countryCode":86,"cosmosGeoPoint":193,"geoPoint":195,"contacts":196},"APHP Hôpital Pitié-Salpêtrière - Service de Chirurgie","75013",{"type":88,"coordinates":194},[173,174],{"lat":174,"lon":173},[197],{"name":198,"role":72,"phone":35,"phoneExt":35,"email":35},"Sébastien Gaujoux, MD PhD",{"facility":200,"status":81,"city":169,"state":83,"zip":192,"country":85,"countryCode":86,"cosmosGeoPoint":201,"geoPoint":203,"contacts":204},"Hôpital Pitié-Salpêtrière - Service de Diabétologie",{"type":88,"coordinates":202},[173,174],{"lat":174,"lon":173},[205,207],{"name":206,"role":72,"phone":35,"phoneExt":35,"email":35},"Chloé Amouyal, MD PhD",{"name":208,"role":110,"phone":35,"phoneExt":35,"email":35},"Fabrizio Andreelli, MD PhD",{"facility":210,"status":81,"city":169,"state":83,"zip":211,"country":85,"countryCode":86,"cosmosGeoPoint":212,"geoPoint":214,"contacts":215},"APHP Hôpital Cochin - Service de Chirurgie","75014",{"type":88,"coordinates":213},[173,174],{"lat":174,"lon":173},[216],{"name":217,"role":72,"phone":35,"phoneExt":35,"email":35},"Pierre-Philippe Massault, MD",{"facility":219,"status":220,"city":169,"state":83,"zip":211,"country":85,"countryCode":86,"cosmosGeoPoint":221,"geoPoint":223,"contacts":224},"APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique","RECRUITING",{"type":88,"coordinates":222},[173,174],{"lat":174,"lon":173},[225],{"name":226,"role":72,"phone":35,"phoneExt":35,"email":35},"Etienne Larger, MD PhD",{"facility":228,"status":81,"city":169,"state":83,"zip":229,"country":85,"countryCode":86,"cosmosGeoPoint":230,"geoPoint":232,"contacts":233},"APHP Hôpital Européen G. Pompidou","75015",{"type":88,"coordinates":231},[173,174],{"lat":174,"lon":173},[234],{"name":235,"role":72,"phone":35,"phoneExt":35,"email":35},"Alina Radu, MD",{"facility":237,"status":81,"city":169,"state":83,"zip":238,"country":85,"countryCode":86,"cosmosGeoPoint":239,"geoPoint":241,"contacts":242},"APHP Hôpital Bichat","75018",{"type":88,"coordinates":240},[173,174],{"lat":174,"lon":173},[243],{"name":244,"role":72,"phone":35,"phoneExt":35,"email":35},"Ronan Roussel, MD PhD",{"facility":246,"status":81,"city":169,"state":83,"zip":247,"country":85,"countryCode":86,"cosmosGeoPoint":248,"geoPoint":250,"contacts":251},"APHP Hôpital R. Debré","75019",{"type":88,"coordinates":249},[173,174],{"lat":174,"lon":173},[252],{"name":253,"role":72,"phone":35,"phoneExt":35,"email":35},"Elise Bismuth, MD",{"facility":255,"status":81,"city":256,"state":83,"zip":257,"country":85,"countryCode":86,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Hôpital René Dubos","Pontoise","95300",{"type":88,"coordinates":259},[260,261],2.1,49.05,{"lat":261,"lon":260},[264],{"name":265,"role":72,"phone":35,"phoneExt":35,"email":35},"Catherine Campinos, MD",{"type":267,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100449999",false,"NCT05139784","BeAT1D: Benign Autoimmunity and Type 1 Diabetes","BeAT1D","Inclusion Criteria:\n\n1. Type 1 diabetes: type 1 diabetes, as defined by hyperglycemia and long-term insulin therapy started within 6 months from clinical onset; and\u002For the presence of at least one anti-islet auto-antibody.\n2. Other forms of diabetes or autoimmune endocrinopathy: other forms of diabetes (e.g. type 2, ketosis-prone, familial, secondary, immunotherapy-induced diabetes); and\u002For other autoimmune endocrinopathies, isolated or multiple.\n3. No diabetes: absence of diabetes or impaired glucose tolerance; absence of tumor, infectious or immune pathologies, or other conditions related to autoimmune or metabolic alterations that may bias the variables under study.\n4. Lymphadenectomy planned in the frame of an abdominal surgery: pancreatic lymphadenectomy planned at the occasion of an abdominal surgery for the treatment of an underlying condition.\n\nExclusion Criteria:\n\nFor all participants: ongoing pregnancy; known HIV\u002FHCV infection; absence of social security coverage; placement under judicial protection; absence of signature of the informed study consent.",true,"ALL","1 Year",{"count":278,"type":279},1160,"ESTIMATED","OBSERVATIONAL","National multi-center non-interventional case-control cohort study with collection of biological samples to characterize the autoimmune T and B lymphocytes involved in the development of type 1 diabetes.",[283],"Type 1 Diabetes",[43,285,286,287,288],"Autoimmunity","Lymphocytes","Beta cells","Biomarkers","2026-05-20",{"date":291,"type":292},"2026-05-22","ACTUAL",{"date":294,"type":292},"2022-10-24",{"date":296,"type":279},"2030-04",{"name":5,"class":6},17]