SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer

NYU Langone Health

Status: Completed

Conditions: Skin Cancer

Treatments: Device: Dermlite Cam; Device: Nevisense 3.0; Device: Barco Demetra; Procedure: Skin biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04411810

19-01242

Details and patient eligibility

About

The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. If successful, the widespread availability of such services would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. With decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma mortality.

Full description

This is a prospective pilot study of a store-and-forward telemedicine diagnostic assessment of participant-selected skin lesions concerning for skin cancer, controlled against an in-person dermatologist assessment (gold standard evaluation). The study will be a single arm design with each participant undergoing telemedicine data acquisition (i.e. clinical and dermoscopic imaging and Nevisense measurement), immediately followed by the in-person dermatologist assessment. The in-person dermatologist will be blinded to the Nevisense score at the time of the visit. Using the telemedicine data, the teledermatology team will render a biopsy/no-biopsy recommendation within 3 business days of the participant evaluation. They will be blinded to the results of the in-person dermatologist's diagnostic evaluation.

Enrollment: 149 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be 18 years of age or older
• Have 1-3 lesions for evaluation

Exclusion criteria

• Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

Participants with skin lesions

Experimental group

Description:

Participants who have up to 3 concerning skin lesions will be evaluated by both an in-person dermatologist and a team of three teledermatologists(board-certified dermatologists). The teledermatoogy team will deliver a consensus recommendation. If either the in-person dermatologist or teledermatologists are concerned that the skin spot(s) may be a skin cancer, a biopsy will be recommended and can be performed at no charge. Or if both agree that the spot(s) are not concerning for skin cancer, no biopsy will be needed.

Treatment:

Device: Barco Demetra

Device: Dermlite Cam

Device: Nevisense 3.0

Procedure: Skin biopsy