Melanoma Clinical Trial

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

Summary

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.

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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.

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Eligibility Criteria

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

Study is for people with:

Melanoma

Estimated Enrollment:

149

Study ID:

NCT04411810

Recruitment Status:

Completed

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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NYU Langone Health
New York New York, 10016, United States

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Study is for people with:

Melanoma

Estimated Enrollment:

149

Study ID:

NCT04411810

Recruitment Status:

Completed

Sponsor:


NYU Langone Health

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