[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566930":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":28,"responsibleParty":59,"collaborators":62,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":10,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":10,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":91,"overallStatus":95,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Auckland, New Zealand","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Healthy volunteers",null,"Male and female healthy volunteers, aged 18 years or over, attending a study specific skin check appointment, without a diagnosis or histology of malignancies.",{"label":13,"type":10,"description":14,"interventionNames":10},"SOC Patients","Participants attending a standard of care medical appointment at a skin clinic, a plastic surgery or a general practitioner for assessment, diagnosis and\u002For potential excision of a skin condition, With confirmatory medical practitioner diagnosis, and where appropriate confirmatory histological analysis of excised tissues",[16],{"name":17,"affiliation":18,"role":19},"Michel K Nieuwoudt, PhD","The University of Auckland","PRINCIPAL_INVESTIGATOR",[21,25],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},"CONTACT","+64210378601","m.nieuwoudt@auckland.ac.nz",{"name":26,"role":22,"phone":10,"phoneExt":10,"email":27},"Paul Jarrett, MBBS,DCCH,MD","Paul.Jarrett@middlemore.co.nz",[29,45],{"facility":30,"status":10,"city":31,"state":10,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Manukau Super clinic","Auckland","0604","New Zealand","NZ",{"type":36,"coordinates":37},"Point",[38,39],174.76349,-36.84853,{"lat":39,"lon":38},[42],{"name":43,"role":22,"phone":44,"phoneExt":10,"email":27},"Paul Jarrett, MBBS, DCCH, DGM,MD, FRCP,FRACP","+6421848109",{"facility":46,"status":10,"city":31,"state":10,"zip":47,"country":33,"countryCode":34,"cosmosGeoPoint":48,"geoPoint":50,"contacts":51},"Sir Willliam Manchester Plastic surgery suite, Middlemore Hosptial","1140",{"type":36,"coordinates":49},[38,39],{"lat":39,"lon":38},[52,56,58],{"name":53,"role":22,"phone":54,"phoneExt":10,"email":55},"Michelle B Locke, BHB, MBChB, MD,FRACS(Plastics)","+6421963533","Michelle.Locke@middlemore.co.nz",{"name":57,"role":22,"phone":10,"phoneExt":10,"email":27},"Paul Jarrett, MBBS,DCCH,MD,DGM,MD,FRCP,FRACP",{"name":17,"role":19,"phone":10,"phoneExt":10,"email":10},{"type":19,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Michel Nieuwoudt","Senior Research Fellow, Principal Investigator, The School of Chemical Sciences",[63,66],{"name":64,"class":65},"Auckland UniServices Ltd.","INDUSTRY",{"name":67,"class":6},"Counties Manukau Health","100566930","an-observational-study-using-the-lumassure-device-in-participants-undergoing-assessment-of-skin-conditions-100566930",false,"NCT06661577","An Observational Study Using The LumAssure Device In Participants Undergoing Assessment Of Skin Conditions.","A Multi-Centre Observational Study For The Collection Of A Raman Spectral Database Using The LumAssure Device In Adult Participants Undergoing Dermatological Assessment Of Skin Conditions","Inclusion Criteria:\n\n* Able to provide informed consent\n* Male or female aged 18 years or over.\n* Willing to undergo a LumAssure device measurement on at least 1 skin condition\n* (For Standard of Care patients): are undergoing a skin examination and\u002For tissue excision by a qualified specialist\n* (For Healthy volunteers): are attending a skin check at a study clinic\n\nExclusion Criteria:\n\n* Tattoo on the skin condition to be measured\n* Skin conditions on or directly around the eye area",true,"ALL","18 Years",{"count":79,"type":80},3000,"ESTIMATED","OBSERVATIONAL","This is an observational study in adult males and females utilising skin condition measurements using the LumAssure Raman device. Data will be used to determine accuracy under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign and cancerous skin conditions. The measurements will provide data which will be used to establish spectral parameters for different skin conditions. Measurements will be benchmarked against diagnoses from medical specialists, and when available confirmed with histological data.\n\nThe main question it aims to answer is :\n\nWhat is the accuracy, in terms of the area under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign skin conditions and skin cancers in adult males and females? Participants include males and females aged ≥18 years who are undergoing assessment of a skin condition (a lesion or rash) by a dermatologist, general practitioner, or plastic surgeon. Participants' attending the clinics will have their skin conditions examined by a clinician. The LumAssure device will then be used to measure Raman spectra of skin conditions and marked by the clinician. The Raman measurements will be benchmarked against skin condition assessment and, where available, diagnosis by a dermatologist, general practitioner, or a plastic surgeon, and for those lesions undergoing biopsy, confirmed with histology data.",[84,85,86,87,88,89,90],"Skin Cancers - Basal Cell Carcinoma","Skin Cancers - Squamous Cell Carcinoma","Melanoma of Skin","Inflammatory Dermatoses","Acral Melanoma","Benign Skin Nevus","Benign Skin Tumor",[92,93,94],"skin cancers","melanoma","diagnostic device","NOT_YET_RECRUITING","2024-10-24",{"date":98,"type":99},"2024-10-28","ACTUAL",{"date":101,"type":80},"2024-12-13",{"date":103,"type":80},"2026-02-28",{"name":5,"class":6},2]