SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense
Time Frame: End of the study (4 weeks)
To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.
Accuracy of Skin Cancer Diagnosis: In-Person Assessment
Time Frame: End of the study (4 weeks)
To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.
Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense
Time Frame: End of the study (4 weeks)
To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.
Secondary Outcomes
- Specificity of In-Person Evaluation in Diagnosing Skin Cancer(End of the study (4 weeks))
- False-Negative Rate of Telemedicine Evaluation: With Nevisense(End of the study (4 weeks))
- Positive Predictive Value of Telemedicine Evaluation: Without Nevisense(End of the study (4 weeks))
- Negative Predictive Value of In-Person Evaluation(End of the study (4 weeks))
- False-Negative Rate of Telemedicine Evaluation: Without Nevisense(End of the study (4 weeks))
- Positive Predictive Value of Telemedicine Evaluation: With Nevisense(End of the study (4 weeks))
- Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense(End of the study (4 weeks))
- False-Negative Rate of In-Person Evaluation(End of the study (4 weeks))
- Negative Predictive Value of Telemedicine Evaluation: Without Nevisense(End of the study (4 weeks))
- Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense(End of the study (4 weeks))
- False-Positive Rate of Telemedicine Evaluation: Without Nevisense(End of the study (4 weeks))
- Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer(End of the study (4 weeks))
- Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense(End of the study (4 weeks))
- Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense(End of the study (4 weeks))
- False-Positive Rate of Telemedicine Evaluation: With Nevisense(End of the study (4 weeks))
- False-Positive Rate of In-Person Evaluation(End of the study (4 weeks))
- Positive Predictive Value of In-Person Evaluation(End of the study (4 weeks))
- Negative Predictive Value of Telemedicine Evaluation: With Nevisense(End of the study (4 weeks))