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PRIME-KS Study

Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202603523439856
Enrollment
150
Registered
2026-03-24
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Standard of care manual ruler based KS lesion assessment
SkinScan3D SS3D AI assisted 2D 3D KS lesion imaging and measurement

Sponsors

Washington University in Saint Louis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age 18 years and above Histopathology-based diagnosis of Kaposi Sarcoma (KS) At least three skin lesions Capable of providing informed consent On treatment for KS (chemotherapy and/or antiretroviral therapy) Patients: histopathology-based KS diagnosis, at least three skin lesions, age 18 years and above, capable of informed consent, and initiating treatment for KS (chemotherapy and/or antiretroviral therapy) Providers: oncologists, medical officers, and nurses involved in delivering KS treatment Administrators: administrators involved in delivering KS treatment

Exclusion criteria

Exclusion criteria: Patients not initiating KS treatment Patients who are very ill / acutely ill and requiring hospitalization Patients, providers, or administrators not willing to participate Patients currently not receiving any treatment for KS Patients who are acutely ill and requiring hospitalization

Design outcomes

Primary

MeasureTime frame
Reproducibility of KS lesion size measurements (CCC), measured at the Aim 1 study assessment visit. Accuracy/agreement of KS lesion size measurements (R-squared; Bland-Altman agreement metrics), measured at the Aim 1 study assessment visit

Secondary

MeasureTime frame
Usability (SUS), acceptability (AIM), appropriateness (IAM), and feasibility (FIM) of SkinScan3D, measured at the end of Aim 2 implementation. Workflow/time-and-motion outcomes, measured during Aim 2 implementation. Implementation/programmatic costs of SS3D versus standard of care, measured during and at the end of Aim 2 implementation. Exploratory correlation of lesion area with lesion height and color, assessed in Aim 1.

Countries

Kenya

Contacts

Public ContactThomas Odeny

Principal Investigator

odeny@wustl.edu+254722819835

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026