Clinical trial NCT04411810: SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
Official title: SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Accuracy of Skin Cancer Diagnosis: In-Person Assessment
timeFrame: End of the study (4 weeks)
measure: Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense
timeFrame: End of the study (4 weeks)
measure: Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense
timeFrame: End of the study (4 weeks)
Secondary outcomes:
measure: Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense
timeFrame: End of the study (4 weeks)
measure: Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense
timeFrame: End of the study (4 weeks)
measure: Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer
timeFrame: End of the study (4 weeks)
measure: Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense
timeFrame: End of the study (4 weeks)
measure: Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense
timeFrame: End of the study (4 weeks)
measure: Specificity of In-Person Evaluation in Diagnosing Skin Cancer
timeFrame: End of the study (4 weeks)
measure: False-Positive Rate of Telemedicine Evaluation: Without Nevisense
timeFrame: End of the study (4 weeks)
measure: False-Positive Rate of Telemedicine Evaluation: With Nevisense
timeFrame: End of the study (4 weeks)
measure: False-Positive Rate of In-Person Evaluation
timeFrame: End of the study (4 weeks)
measure: False-Negative Rate of Telemedicine Evaluation: Without Nevisense
timeFrame: End of the study (4 weeks)
measure: False-Negative Rate of Telemedicine Evaluation: With Nevisense
timeFrame: End of the study (4 weeks)
measure: False-Negative Rate of In-Person Evaluation
timeFrame: End of the study (4 weeks)
measure: Positive Predictive Value of Telemedicine Evaluation: Without Nevisense
timeFrame: End of the study (4 weeks)
measure: Positive Predictive Value of Telemedicine Evaluation: With Nevisense
timeFrame: End of the study (4 weeks)
measure: Positive Predictive Value of In-Person Evaluation
timeFrame: End of the study (4 weeks)
measure: Negative Predictive Value of Telemedicine Evaluation: Without Nevisense
timeFrame: End of the study (4 weeks)
measure: Negative Predictive Value of Telemedicine Evaluation: With Nevisense
timeFrame: End of the study (4 weeks)
measure: Negative Predictive Value of In-Person Evaluation
timeFrame: End of the study (4 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Polsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: