NCT03050788

Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Kaposi Sarcoma

Interventions

Type	Name	Description
DEVICE	Smartphone confocal microscopy	Imaging of skin lesion using the smartphone confocal microscopy

Timeline

• Start date: 2017-03-10
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2017-02-13
• Last updated: 2020-10-26

Locations

1 site across 1 country: Uganda