[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585118":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":29,"armGroups":35,"interventions":45,"overallOfficials":53,"centralContacts":57,"locations":62,"responsibleParty":103,"collaborators":105,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":124,"minAge":125,"maxAge":29,"enrollmentInfo":126,"targetDuration":29,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":86,"whyStopped":29,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":29},[9,13,16,20,23,26],{"measure":10,"description":11,"timeFrame":12},"Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only","Reproducibility\u002Fagreement between clinicians for each method is measured using the concordance correlation coefficient (CCC). A higher CCC means a more reproducible method.","Approximately 3 months",{"measure":14,"description":15,"timeFrame":12},"Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only","Accuracy is measured using the coefficient of determination (R-squared). The R-squared tells us how much variation is due to varying lesion size as measured by either method versus how much variation is due to random error. When the variation due to random error is small, the R-squared value is closer to 1; when the variation due to random error is large, the R-squared value is farther from 1.",{"measure":17,"description":18,"timeFrame":19},"Device usability - Aim 3 Only","Device usability will be measured using the System Usability Scale. The SUS will result in a single composite score for each individual and the scores will be averaged to result in a single overall usability score.","6 months",{"measure":21,"description":22,"timeFrame":19},"Acceptability - Aim 3 Only","Acceptability of Intervention Measure (AIM), present participants with a set of 4 questions regarding their perception of an intervention's acceptability, typically on a 5-point Likert scale (completely disagree to completely agree), then calculate the average score across all items, with higher scores indicating greater perceived acceptability of the intervention.",{"measure":24,"description":25,"timeFrame":19},"Appropriateness - Aim 3 Only","Intervention Appropriateness Measure (IAM), will present a set of four questions to healthcare providers about how well SS3D works in their context. Each item is rated on a Likert scale, with higher scores indicating greater perceived appropriateness.",{"measure":27,"description":28,"timeFrame":19},"Feasibility - Aim 3 Only","FIM (Feasibility of Intervention Measure), will give the four-item questionnaire to healthcare providers asking them to rate how feasible they believe a specific intervention is on a Likert scale, usually ranging from \"completely disagree\" to \"completely agree\"; a higher score indicates greater perceived feasibility, with the average score across all items representing the overall feasibility rating of the intervention in that context.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":6,"observationalModel":29,"timePerspective":29,"maskingInfo":33},"NON_RANDOMIZED","PARALLEL",{"masking":34,"maskingDescription":29,"whoMasked":29},"NONE",[36,41],{"label":37,"type":6,"description":38,"interventionNames":39},"Aim 2: Patients","Patients will have three discrete skin lesions measured, with lesion area determined by ACTG criteria utilizing the product of longest perpendicular diameters. Patients will also have five 3D snapshots of each of the three target lesions taken, measuring lesion area automatically using SS3D.",[40],"Device: SkinScan3D",{"label":42,"type":6,"description":43,"interventionNames":44},"Aim 3: Patients","Providers will first measure KS lesions using the manual ruler-based method as per usual standard of care for the first three months. After the first three months, providers will switch to using SkinScan3D for KS skin lesion measurement.",[40],[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DEVICE","SkinScan3D","A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).",[37,42],[52],"SS3D",[54],{"name":55,"affiliation":5,"role":56},"Thomas Odeny, MBChB, MPH, PhD","PRINCIPAL_INVESTIGATOR",[58],{"name":55,"role":59,"phone":60,"phoneExt":29,"email":61},"CONTACT","314-273-3022","odeny@wustl.edu",[63,84],{"facility":64,"status":65,"city":66,"state":29,"zip":29,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Kenya Medical Research Institute","NOT_YET_RECRUITING","Kisumu","Kenya","KE",{"type":70,"coordinates":71},"Point",[72,73],34.76171,-0.10221,{"lat":73,"lon":72},[76,80,81],{"name":77,"role":59,"phone":78,"phoneExt":29,"email":79},"Elizabeth Bukusi, MBChB, MMED, MPH, PhD","+254 0722 205 901","ebukusi@kemri.go.ke",{"name":77,"role":56,"phone":29,"phoneExt":29,"email":29},{"name":82,"role":83,"phone":29,"phoneExt":29,"email":29},"Victor Mudhune, Bpharm","SUB_INVESTIGATOR",{"facility":85,"status":86,"city":87,"state":29,"zip":29,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Infectious Diseases Institute, Makerere University","RECRUITING","Kampala","Uganda","UG",{"type":70,"coordinates":91},[92,93],32.58219,0.31628,{"lat":93,"lon":92},[96,100,101],{"name":97,"role":59,"phone":98,"phoneExt":29,"email":99},"Aggrey Semeere, MBChB, MMed, MAS, FCP (ECSA)","+256 772 621181","aseeere@idi.co.ug",{"name":97,"role":56,"phone":29,"phoneExt":29,"email":29},{"name":102,"role":83,"phone":29,"phoneExt":29,"email":29},"Fred Okuku, MBChB, MMed",{"type":104,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[106,109,112,113],{"name":107,"class":108},"National Cancer Institute (NCI)","NIH",{"name":110,"class":111},"Pensievision","UNKNOWN",{"name":64,"class":6},{"name":114,"class":6},"Makerere University","100585118","precision-imaging-to-evaluate-kaposi-sarcoma-100585118",false,"NCT06898203","Precision Imaging to Evaluate Kaposi Sarcoma","Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)","PRIME-KS","Inclusion Criteria - Aim 2 (Patients):\n\n* Adults age ≥18 years old\n* Histopathology-confirmed Kaposi Sarcoma\n* At least 3 skin lesions\n* Capable of informed consent\n* On treatment for Kaposi Sarcoma\n\nExclusion Criteria - Aim 2 (Patients):\n\n* Patients not initiating Kaposi Sarcoma treatment\n* Very ill patients requiring hospitalization\n\nInclusion Criteria - Aim 3 (Patients):\n\n* Adults age ≥18 years old\n* Histopathology-confirmed Kaposi Sarcoma\n* Capable of informed consent\n* Initiating treatment for Kaposi Sarcoma\n\nExclusion Criteria - Aim 3 (Patients):\n\n* Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2\n* Prior or ongoing Kaposi Sarcoma treatment",true,"ALL","18 Years",{"count":127,"type":128},180,"ESTIMATED","INTERVENTIONAL",[131],"NA","AIMS 2 \\& 3:\n\nIn this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.",[134],"Kaposi Sarcoma",[136,134,137,138,139,140,141,142,143],"Global Oncology","Affordable Cancer Technologies","Cancer in People with HIV","Human Centered Design","Discrete Choice Experiment","Medical devices","Low-cost design","Global health","2026-09-15",{"date":146,"type":147},"2026-09-21","ACTUAL",{"date":149,"type":147},"2026-04-10",{"date":151,"type":128},"2029-11-30",{"name":5,"class":6},2]