Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01CA292765 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Pensievision | UNKNOWN |
| Kenya Medical Research Institute | OTHER |
| Makerere University |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 2: Patients | Other | 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. |
|
| Aim 3: Patients | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SkinScan3D | Device | A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 3 months |
| 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. | Approximately 3 months |
| 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 |
| 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. | 6 months |
| 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. |
Not provided
Not provided
Inclusion Criteria - Aim 2 (Patients):
Exclusion Criteria - Aim 2 (Patients):
Inclusion Criteria - Aim 3 (Patients):
Exclusion Criteria - Aim 3 (Patients):
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Odeny, MBChB, MPH, PhD | Contact | 314-273-3022 | odeny@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Odeny, MBChB, MPH, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute | Not yet recruiting | Kisumu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42282156 | Derived | Odeny TA, Adhiambo HF, Mangale D, Makanga PK, Odeny B, Okuku F, Zhou C, Geng EH, Carson J, Mudhune V, Bukusi EA, Semeere A. Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): protocol for a multicountry novel artificial intelligence-based imaging device. medRxiv [Preprint]. 2026 Jun 4:2026.06.03.26354815. doi: 10.64898/2026.06.03.26354815. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
All participants will consent to the sharing of aggregate de-identified quantitative and qualitative data. Any potentially identifying variables will be stripped from the public-use data in compliance with Washington University IRB policies and human subject protections. Participants will have the option to consent to sharing their identifiable survey data for future research and scholarly use as part of a data donation agreement. These identifiable data will be made available as a separate, identifiable dataset in WURD. All deidentified study data that are not designated as restricted use will be made available as public use data to the research community via the WURD or QDR. Data that are determined to be potentially identifying though indirect or deductive disclosure are provided under restricted data contract to users who have a valid research need and meet conditions of use.
All data associated with study will be made available at the time of the first publication associated with the data. We anticipate that this will occur approximately 12 months following the completion of field work and within the award period. Study data deposited in WURD and QDR will be available to the public in perpetuity. Datasets related to methodological publications will be shared at publication.
Contact Dr. Thomas Odeny
Not provided
Not provided
| ID | Term |
|---|---|
| D012514 | Sarcoma, Kaposi |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 6 months |
| 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. | 6 months |
| Infectious Diseases Institute, Makerere University | Recruiting | Kampala | Uganda |
|
| Related Info | View source |
| Related Info | View source |
| D012509 |
| Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |