[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560981":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":50,"collaborators":19,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":19,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":19,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":19,"overallStatus":71,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Abbott Rapid Dx","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Diagnostic test: Determine™ Syphilis Advanced test","EXPERIMENTAL","Diagnostic test: Testing using the Determine™ Syphilis Advanced test will be conducted by study staff members.",[13],"Diagnostic Test: Diagnostic test: Determine™ Syphilis Advanced test",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","The Determine™ Syphilis Advanced test is intended as an aid in detecting antibodies to Treponema pallidum in individuals with current or past infection.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Pontiano Kaleebu, Professor, MD PhD","MRC\u002FUVRI and LSHTM Uganda Research Unit","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Camilla Forssten, PhD","CONTACT","+44 7792 902 244","camilla.forssten@abbott.com",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Simon Kordowich, PhD","+49 162-136-8985","simon.kordowich@abbott.com",[36],{"facility":37,"status":19,"city":38,"state":19,"zip":19,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Uganda Virus Research Institute","Entebbe","Uganda","UG",{"type":42,"coordinates":43},"Point",[44,45],32.47949,0.05621,{"lat":45,"lon":44},[48],{"name":22,"role":28,"phone":19,"phoneExt":19,"email":49},"Pontiano.Kaleebu@mrcuganda.org",{"type":51,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100560981","evaluation-of-the-diagnostic-sensitivity-and-specificity-of-the-determine-syphilis-advanced-test-100560981",false,"NCT06584214","Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.","A Prospective, Multi-centre Study to Evaluate the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.","Inclusion Criteria:\n\n* 12 years of age or older.\n* The participant has confirmed previous \u002F current syphilis according to their medical history, or the participant has unknown or negative syphilis infection status.\n* The participant agrees to provide written informed consent.\n* The participant agrees to complete all aspects of the study.\n\nAdditional inclusion criteria for frozen samples:\n\n* The ethics committee-required written informed consent for study testing, or required documentation for sample use from a commercial vendor, is available.\n* Sufficient volume for testing is available and the sample quality is adequate (for example no significant sample hemolysis)\n* The sample must have been collected in EDTA vacutainers or serum tubes, processed to plasma and the plasma frozen within 36 hours of blood collection.\n\nExclusion Criteria:\n\n* Participant has already participated in this study on a previous occasion.\n* Participant is deemed vulnerable and \u002F or unfit for participation in the study by the Investigator.\n* Participant is unwilling or unable to provide informed consent.\n* Participant is currently enrolled in a study to evaluate an investigational new drug or vaccine.\n\nAdditional exclusion criteria for frozen samples\n\n* The sample has undergone more than one freeze thaw cycle\n* The sample has been kept at -20 °C (± 5 °C) longer than 12 months. If the sample has been kept longer than 12 months, the storage temperature must have been colder than -20 °C (± 5 °C).",true,"ALL","12 Years",{"count":63,"type":64},400,"ESTIMATED","INTERVENTIONAL",[67],"NA","This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. The study will also have a retrospective study arm. The Determine™ Syphilis Advanced validation will be conducted in accordance with the World Health Organization\\'s TSS-6 guidance on Syphilis rapid diagnostic tests, ISO 20916 (In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice), the study protocol, Good Clinical Practice and the respective local medical device laws.",[70],"Syphilis Infection","NOT_YET_RECRUITING","2024-09-02",{"date":74,"type":75},"2024-09-04","ACTUAL",{"date":77,"type":64},"2024-09",{"date":79,"type":64},"2024-12",{"name":5,"class":6},1]