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Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050788
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : October 26, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Infectious Diseases Institute, Uganda
Information provided by (Responsible Party):
Dongkyun Kang, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Kaposi Sarcoma Device: Smartphone confocal microscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020


Arm Intervention/treatment
Experimental: Smartphone confocal microscopy imaging
Subject's skin lesion will be imaged with the smartphone confocal microscopy.
Device: Smartphone confocal microscopy
Imaging of skin lesion using the smartphone confocal microscopy




Primary Outcome Measures :
  1. Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy [ Time Frame: Approximately 20 minutes (10 minutes for in vivo imaging) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050788


Locations
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Uganda
Infectious Diseases Institute
Kampala, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Infectious Diseases Institute, Uganda
Investigators
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Principal Investigator: Dongkyun Kang, PhD Massachusetts General Hospital
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Responsible Party: Dongkyun Kang, Assistant Professor of Dermatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03050788    
Other Study ID Numbers: 2016P002672
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dongkyun Kang, Massachusetts General Hospital:
Smartphone confocal microscopy
Kaposi Sarcoma
Point of care diagnosis
Additional relevant MeSH terms:
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Sarcoma, Kaposi
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue