Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03050788

Enrollment

363

Registered

2017-02-13

Start date

2017-03-10

Completion date

2020-02-28

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kaposi Sarcoma

Keywords

Smartphone confocal microscopy, Kaposi Sarcoma, Point of care diagnosis

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.

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.

Interventions

DEVICESmartphone confocal microscopy

Imaging of skin lesion using the smartphone confocal microscopy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy	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.

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026