This trial compares enhanced telemedicine versus in-person evaluation in diagnosing skin cancer. Telemedicine allows health care professionals to remotely evaluate, diagnose, and treat patients (i.e. without seeing a patient in person). A dermatologist who is not seeing a patient in person is called a teledermatologist. This trial is being done to determine whether a teledermatologist can correctly diagnose skin cancer with the same accuracy as an in-person dermatologist.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04411810.
PRIMARY OBJECTIVE:
I. To assess the concordance in biopsy recommendations between the in-person dermatologist evaluation and the enhanced telemedicine evaluation of participant-identified skin lesions concerning for skin cancer in a walk-in clinic setting.
SECONDARY OBJECTIVES:
I. To compare the diagnostic accuracy of the enhanced telemedicine method, and its separate individual components (Nevisense, teledermoscopy), to the in-person dermatologist with respect to the diagnosis of skin cancer (confirmed histopathologically).
II. To assess patient satisfaction and preferences (patient-centered outcomes) regarding the teledermatologist evaluation for skin lesions suspicious for skin cancer.
III. To determine the proportion of participant-selected skin lesions for which the Nevisense measurement would be considered appropriate by the in-person and teledermatologists.
IV. To create a database of dermoscopic images and Nevisense scores of the benign and malignant skin lesions encountered in the walk-in clinic setting.
OUTLINE:
Patients undergo photo imaging of skin lesions and measurements using Nevisense device for telemedicine evaluation followed by in-person skin lesion evaluation by dermatologist over 30-90 minutes. Patients may undergo biopsy if recommended by dermatologist or teledermatologist.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorDavid Polsky