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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03050788
Other study ID # 2016P002672
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2017
Est. completion date February 28, 2020

Study information

Verified date October 2020
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Smartphone confocal microscopy
Imaging of skin lesion using the smartphone confocal microscopy

Locations

Country Name City State
Uganda Infectious Diseases Institute Kampala

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital Infectious Diseases Institute, Uganda, National Institutes of Health (NIH)

Country where clinical trial is conducted

Uganda, 

Outcome

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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