N/A
N=149
SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04411810 ↗Enrolled (actual)
149
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Accuracy of Skin Cancer Diagnosis: In-Person Assessment — 93 percentage of skin lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nevisense 3.0 (Device); Dermlite Cam (Device); Skin biopsy (Procedure); Barco Demetra (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Skin Cancer Diagnosis: In-Person Assessment |
93 | — |
| PRIMARY Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense |
91 | — |
| PRIMARY Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense |
83 | — |
| SECONDARY Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense |
85 | — |
| SECONDARY Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense |
92 | — |
| SECONDARY Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer |
85 | — |
| SECONDARY Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense |
91 | — |
| SECONDARY Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense |
83 | — |
| SECONDARY Specificity of In-Person Evaluation in Diagnosing Skin Cancer |
93 | — |
| SECONDARY False-Positive Rate of Telemedicine Evaluation: Without Nevisense |
9 | — |
| SECONDARY False-Positive Rate of Telemedicine Evaluation: With Nevisense |
17 | — |
| SECONDARY False-Positive Rate of In-Person Evaluation |
7 | — |
| SECONDARY False-Negative Rate of Telemedicine Evaluation: Without Nevisense |
1 | — |
| SECONDARY False-Negative Rate of Telemedicine Evaluation: With Nevisense |
— | — |
| SECONDARY False-Negative Rate of In-Person Evaluation |
1 | — |
| SECONDARY Positive Predictive Value of Telemedicine Evaluation: Without Nevisense |
26 | — |
| SECONDARY Positive Predictive Value of Telemedicine Evaluation: With Nevisense |
16 | — |
| SECONDARY Positive Predictive Value of In-Person Evaluation |
31 | — |
| SECONDARY Negative Predictive Value of Telemedicine Evaluation: Without Nevisense |
99 | — |
| SECONDARY Negative Predictive Value of Telemedicine Evaluation: With Nevisense |
100 | — |
| SECONDARY Negative Predictive Value of In-Person Evaluation |
99 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04411810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.