Early Stage Diagnosis of Kaposi's Sarcoma in Limited Resource Settings using KS-Detect

-
Investigator: Jeffrey N. Martin, MD, MPH
Sponsor: Cornell University

Location(s): Uganda

Description

Kaposi's sarcoma (KS) is one of the most common cancers in sub-Saharan Africa, and, like other tumors, early detection can lead to improved survival. The goal of this project is to field-test, optimize, and demonstrate the clinical utilityin enhancing early KS detection of a newly developed inexpensive point-of-care diagnostic test for KS in limited resource settings, which we call 'KS-Detect'.

 In this project, we will field-test and clinically validate a rapid, point-of-care platform for the diagnosis of Kaposi's sarcoma (KS) in limited resource settings. Our KS-Detect diagnostic platform uses solar- power and smartphone technology enabling it to be operated without reliance on any external infrastructure, while maintaining a high degree of usability with low per-unit cost. The ability to provide rapid confirmatory diagnosis of KS promises to facilitate earlier detection of KS in the community at a clinical stage when it?s more responsive to therapy. Specific diagnosis of KS also prevents inappropriate therapy of clinical mimickers of KS. By the end of the project, we will have demonstrated both the field efficacy of the diagnostic technology as well as quantifiably evaluated its effect on promoting earlier detection of KS. To achieve this, we have brought together a team of engineers, local physicians, clinical epidemiologists, business people, translation partners, and entrepreneurs from Cornell, UC-San Francisco and the Infectious Diseases Institute in Kampala, Uganda. Prof. David Erickson (Contact- PI, Cornell), an engineer and entrepreneur from Cornell University, is the original developer of the KS- Detect technology and will lead the engineering and product development efforts while Prof. Jeff Martin (PI, UCSF), a KS epidemiologist and Prof. Toby Maurer (UCSF), a clinician, will lead the clinical and deployment efforts along with our partners in Uganda. Dr. Ethel Cesarman (Weill Cornell) as one of the original discoverers of the virus that causes KS, will lead the local molecular pathology effort. We will develop a dual-use platform that can be powered by either direct solar heating, solar panels, or conventional electrical outlet to enable both field and lab operation without changing the analysis method. In Phase I of this project, we will (1) collect 500 samples from our Ugandan partner site and validate the PCR based assay; (2) construct a set of field ruggedized dual use KS-Detect systems and consumables; and (3) deploy 5 units for 3 months with local health technicians. If successful, in Phase II we will perform an extensive field study deploying 17 KS-Detect units in Uganda, operated and serviced by locally trained clinicians, and demonstrate the ability of the system to enable earlier stage detection of KS than existing diagnostic procedures.