Kaposi SarcomaPRIME-KSNCT06898203
Precision Imaging to Evaluate Kaposi Sarcoma
A study testing SkinScan3D in people with Kaposi Sarcoma, run by Washington University School of Medicine at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kaposi Sarcoma
- What is being tested?
- SkinScan3D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Apr 2026to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age ≥18 years old
- Histopathology-confirmed Kaposi Sarcoma
- At least 3 skin lesions
- Capable of informed consent
- On treatment for Kaposi Sarcoma
- Adults age ≥18 years old
Show all 9Show fewer
- Histopathology-confirmed Kaposi Sarcoma
- Capable of informed consent
- Initiating treatment for Kaposi Sarcoma
Who cannot join
- Patients not initiating Kaposi Sarcoma treatment
- Very ill patients requiring hospitalization
- Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2
- Prior or ongoing Kaposi Sarcoma treatment
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Kenya1 site, 1 recruiting
- Not yet recruiting
Kenya Medical Research Institute
Kisumu
Elizabeth Bukusi, MBChB, MMED, MPH, PhD, +254 0722 205 901, ebukusi@kemri.go.ke
Elizabeth Bukusi, MBChB, MMED, MPH, PhD
Uganda1 site, 1 recruiting
- Recruiting
Infectious Diseases Institute, Makerere University
Kampala
Aggrey Semeere, MBChB, MMed, MAS, FCP (ECSA), +256 772 621181, aseeere@idi.co.ug
Aggrey Semeere, MBChB, MMed, MAS, FCP (ECSA)
About this study
Official title: Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)
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.
- Conditions
- Kaposi Sarcoma
- Being tested
- SkinScan3D
- Keywords
- Global Oncology, Kaposi Sarcoma, Affordable Cancer Technologies, Cancer in People with HIV, Human Centered Design, Discrete Choice Experiment, Medical devices, Low-cost design, Global health
- Medical subject headings
- Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkinScan3DDevice
Also called SS3D
A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SkinScan3D |
| 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. Receives: Device: SkinScan3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start10 Apr 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kaposi SarcomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pensievision, Kenya Medical Research Institute, Makerere University
- Responsible party
- Sponsor
- Investigators
- Thomas Odeny, MBChB, MPH, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898203
- Sponsor's protocol ID
- 202411179
- Other IDs
- U01CA292765
- Acronym
- PRIME-KS
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 42282156
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)
- ClinicalTrials.gov ID
- NCT06898203
- Acronym / sponsor ID
- PRIME-KS / 202411179
- Conditions
- Kaposi Sarcoma
- Keywords
- Global Oncology, Kaposi Sarcoma, Affordable Cancer Technologies, Cancer in People with HIV, Human Centered Design, Discrete Choice Experiment, Medical devices, Low-cost design
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pensievision, Kenya Medical Research Institute, Makerere University
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 2: Patients | Other | Device: SkinScan3DPatients 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 | Device: SkinScan3DProviders 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults age ≥18 years old
- Histopathology-confirmed Kaposi Sarcoma
- At least 3 skin lesions
- Capable of informed consent
- On treatment for Kaposi Sarcoma
Key exclusion criteria (4 listed)
- Patients not initiating Kaposi Sarcoma treatment
- Very ill patients requiring hospitalization
- Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2
- Prior or ongoing Kaposi Sarcoma treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SkinScan3DAlso: SS3DA handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI). | Device | Aim 2: Patients, Aim 3: Patients |
Primary outcome
Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
Time frame: Approximately 3 months
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
Time frame: Approximately 3 months
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
Time frame: 6 months
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
Time frame: 6 months
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.
Appropriateness - Aim 3 Only
Time frame: 6 months
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.
Feasibility - Aim 3 Only
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 42282156Odeny 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.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Odeny, MBChB, MPH, PhD principal investigator
Washington University School of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SkinScan3D in people with Kaposi Sarcoma, run by Washington University School of Medicine at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Odeny, MBChB, MPH, PhD (314-273-3022, odeny@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only (time frame: Approximately 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06898203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.