About this trial
AIMS 2 \& 3:
In 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults age ≥18 years old
Histopathology-confirmed Kaposi Sarcoma
At least 3 skin lesions
Capable of informed consent
Disqualifiers
Patients not initiating Kaposi Sarcoma treatment
Very ill patients requiring hospitalization
Adults age ≥18 years old
Histopathology-confirmed Kaposi Sarcoma
Trial design
Parallel
Treatments tested in this trial
SkinScan3D
DeviceA handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).
Treatment groups
Trial outcomes
Primary outcomes
Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
Reproducibility/agreement between clinicians for each method is measured using the concordance correlation coefficient (CCC). A higher CCC means a more reproducible method.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Pensievision
Collaborator
Kenya Medical Research Institute
Collaborator
Makerere University
Collaborator