Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

Study Overview
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Brief Summary
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The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS) that may be eventually deployed with portable, point-of-care techniques. This approach features confocal microscopy. The investigators will compare this new approach with the gold standard of histology from a traditional skin punch biopsy (which is standard of care) to determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.

Detailed Description
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The investigators will perform a cross-sectional study of 500 patients in routine clinical care settings who are suspected to have KS on clinical grounds and for whom skin punch biopsy and histopathological examination is indicated as part of standard of care. Patients will be evaluated with both the gold standard for diagnosis of KS (skin punch biopsy followed by histopathology) and portable confocal microscopy.

Official Title
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Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

Conditions
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Kaposi Sarcoma

Intervention / Treatment
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* Device: Smartphone confocal microscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i. ≥ 18 years old ii. Clinically suspected KS iii. Presence of suspected KS lesions in areas which are considered safe to biopsy by the Ugandan providers, which means all areas of the skin except for the mouth and eye. Exclusion Criteria: i. Presence of suspected KS lesions exclusively on the mouth or eye unless clinical specialists trained in biopsy of the mouth or eye are available locally to biopsy the mouth or eye. Oral and eye sites would typically only be biopsied when clinical diagnosis has proved to be problematic and definitive diagnosis is needed to inform a treatment plan.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone confocal microscopy imaging<br>Subject's skin lesion will be imaged with the smartphone confocal microscopy. | Device: Smartphone confocal microscopy<br>* Imaging of skin lesion using the smartphone confocal microscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy | Confocal microscopy images obtained from the skin lesion will be compared with the corresponding histologic images. Diagnostic accuracy will be tested. No clinical decisions will be made based on confocal microscopy images. | Approximately 20 minutes (10 minutes for in vivo imaging) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartphone confocal microscopy, Kaposi Sarcoma, Point of care diagnosis