Kaposi Sarcoma Clinical Trial
Official title:
Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
Verified date | October 2020 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 363 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Uganda | Infectious Diseases Institute | Kampala |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Infectious Diseases Institute, Uganda, National Institutes of Health (NIH) |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
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