[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100336346":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":23,"responsibleParty":39,"collaborators":7,"id":41,"slug":7,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":7,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":7,"enrollmentInfo":49,"targetDuration":7,"studyType":52,"phases":7,"briefSummary":53,"conditions":54,"keywords":63,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Saskia Oro, MD","APHP","PRINCIPAL_INVESTIGATOR",[14,19],{"name":10,"role":15,"phone":16,"phoneExt":17,"email":18},"CONTACT","0149812536","+33","saskia.oro@aphp.fr",{"name":20,"role":15,"phone":21,"phoneExt":17,"email":22},"Laetitia Gregoire","0149814164","laetitia.gregoire@aphp.fr",[24],{"facility":25,"status":26,"city":27,"state":7,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Henri Mondor","RECRUITING","Créteil","94010","France","FR",{"type":32,"coordinates":33},"Point",[34,35],2.46569,48.79266,{"lat":35,"lon":34},[38],{"name":10,"role":15,"phone":7,"phoneExt":7,"email":7},{"type":40,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100336346",false,"NCT03659227","Drug Reactions Sampling (COLLECTIONTOXIDERMIES)","Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples","Inclusion Criteria:\n\n* Patient ≥ 18 y-old\n* Severe cutaneous drug reaction (AGEP, DRESS, SJS\u002FTEN, generalized bullous fixed drug eruption), drug-induced IgA bullous dermatosis, maculopapular exanthema, erythema multiforme\n* Signed consent\n* Social security affiliation\n\nExclusion Criteria:\n\n* Patients law protection","ALL","18 Years",{"count":50,"type":51},500,"ESTIMATED","OBSERVATIONAL","Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed drug reactions, AGEP, DRESS, drug induced immunoglobulin A (IgA) bullous dermatosis, and erythema multiforme). In order to conduct clinical and biological research studies in drug reactions, it is necessary for the investigator's department to implement a collection of clinical data and biological samples.\n\nHypothesis\u002FObjective: To collect clinical data and cutaneous and biological samples for immunological, biological and genetic studies to improve knowledge about pathophysiology of drug reactions.\n\nMethod: The following samples will be performed in addition to the routine practice samples: one skin punch biopsy (6mm); 43 mL of blood; blister fluid aspiration; oral and nose mucous membrane and skin eSWABs, stool samples.\n\nThese samples will be stored in a dedicated biological sampling department (\"Platform of biological resources\").\n\nConclusion: The implementation of this collection should allow us to conduct pathophysiological studies about drug reactions.",[55,56,57,58,59,60,61,62],"Stevens-Johnson Syndrome","Lyell Syndrome","Drug Reactions","AGEP","DRESS","Bullous Dermatosis Caused by Drug Treatment (Disorder)","Maculopapular Exanthem","Erythema Multiforme",[64,65,66,56,67,58,59,68,69,70,71,72],"Drug reactions","severe cutaneous adverse reactions (SCARs","Stevens-Johnson syndrome","(generalized bullous) fixed drug reaction","drug induced IgA bullous dermatosis","maculopapular exanthema","erythema multiforme","sampling","collection","2022-05-02",{"date":75,"type":76},"2022-05-03","ACTUAL",{"date":78,"type":76},"2018-09-26",{"date":80,"type":51},"2028-09-25",{"name":5,"class":6},1]