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Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

NCT ID: NCT03050788

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2020-02-28

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.

Conditions

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Kaposi Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Smartphone confocal microscopy imaging

Subject's skin lesion will be imaged with the smartphone confocal microscopy.

Group Type EXPERIMENTAL

Smartphone confocal microscopy

Intervention Type DEVICE

Imaging of skin lesion using the smartphone confocal microscopy

Interventions

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Smartphone confocal microscopy

Imaging of skin lesion using the smartphone confocal microscopy

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Infectious Diseases Institute, Uganda

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dongkyun Kang

Assistant Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dongkyun Kang, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Infectious Diseases Institute

Kampala, , Uganda

Site Status

Countries

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Uganda

Other Identifiers

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2016P002672

Identifier Type: -

Identifier Source: org_study_id