[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558089":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":57,"collaborators":20,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":20,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","All participants will be asked to perform self-sampling and irrespective of the result will receive current standard-of-care from their health care provider for their suspected scabies.",[13],"Diagnostic Test: Skin sampling",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Skin sampling","All individuals will self-collect skin samples and swabs and fill in a questionnaire. Subsequently, all individuals will see a professional. The professional will collect skin samples and swabs as well.",[9],null,[22,28],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Matthew MC McCall, PhD","CONTACT","024 361 1111","+31","matthew.mccall@radboudumc.nl",{"name":29,"role":24,"phone":25,"phoneExt":26,"email":30},"Saskia C van der Boor, PhD","saskia.vanderboor@radboudumc.nl",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Radboudumc","RECRUITING","Nijmegen","Gelderland","6525GA","Netherlands","NL",{"type":41,"coordinates":42},"Point",[43,44],5.85278,51.8425,{"lat":44,"lon":43},[47,48,49,52,55],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},{"name":29,"role":24,"phone":25,"phoneExt":26,"email":30},{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},"Suzanne Roos-Soethoudt, MSc","SUB_INVESTIGATOR",{"name":53,"role":54,"phone":20,"phoneExt":20,"email":20},"Stijn Raven, PhD","PRINCIPAL_INVESTIGATOR",{"name":56,"role":54,"phone":20,"phoneExt":20,"email":20},"Jeannine Hautvast, PhD",{"type":58,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100558089","early-phase-1-sensitivity-of-self-collected-skin-sampling-for-scabies-a-pilot-study-100558089",false,"NCT06546579","Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study","SCRAPE","Inclusion Criteria:\n\n* 18 years or older\n* Have either suspected scabies, clinical scabies or confirmed scabies (see table 1)\n* Providing informed consent (IC)\n\nExclusion Criteria:\n\n* Individuals not speaking or understanding the Dutch or English language.\n* Individuals who have been diagnosed with scabies in the last six weeks and had started treatment.\n* Individuals who have used ivermectin for other diagnoses than scabies in the last six weeks.\n* Individuals younger than 18 years.\n* Individuals with immunosuppressive conditions (see appendix A).\n* Any other condition, finding or situation which, in the opinion of the investigator, may significantly increase the risk to the individual because of participation in the study, affect the ability of the individual to participate in the study or impair interpretation of the study data.",true,"ALL","18 Years",{"count":70,"type":71},144,"ESTIMATED","INTERVENTIONAL",[74],"EARLY_PHASE1","In this cross-sectional diagnostic study, healthy adults aged 18 and older with suspected, clinical, or confirmed scabies will be recruited. The objective is to determine if the sensitivity of self-collected skin samples for scabies diagnosis is non-inferior to professional sampling, and compare the sensitivity and specificity of the polymerase chain reaction assay (PCR) versus microscopy.",[77],"Scabies","2024-08-06",{"date":80,"type":81},"2024-08-09","ACTUAL",{"date":83,"type":71},"2024-08-21",{"date":85,"type":71},"2025-06",{"name":5,"class":6},1]