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

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.

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

Conditions
-----------------
Skin Cancer

Intervention / Treatment
-----------------
* Device: Nevisense 3.0
* Device: Dermlite Cam
* Procedure: Skin biopsy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with skin lesions<br>Participants who have up to 3 concerning skin lesions will be evaluated by both an in-person dermatologist and a team of three teledermatologists(board-certified dermatologists). The teledermatoogy team will deliver a consensus recommendation. If either the in-person dermatologist or teledermatologists are concerned that the skin spot(s) may be a skin cancer, a biopsy will be recommended and can be performed at no charge. Or if both agree that the spot(s) are not concerning for skin cancer, no biopsy will be needed. | Device: Nevisense 3.0<br>* Nevisense, an AI-based point-of-care system for the non-invasive evaluation of irregular moles remains the only FDA approved system available for melanoma detection in the US. Nevisense 3.0 will be used as a one-time exposure of <8 seconds per lesion. Disposable electrodes that contact the participant are 5mm x 5mm in size. Nevisense 3.0 measures electrical impedance of skin lesions and provides an output called the electrical impedence spectroscopy (EIS) score. Electrical impedance is a measure of a material's overall resistance to the flow of alternating electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal tissue.<br>Device: Dermlite Cam<br>* Dermlite Cam is a digital camera that captures images of the skin under cross-polarized and non-polarized light and is 510(k) exempt. The DermLite Cam device appears as a single piece camera with a charging cable and USB computer cable. As part of the camera unit, an extensor arm exists to allow for the capture of standardized clinical images. The DermLite Cam will be used to acquire 3 images of <5 seconds per lesion (one clinical, one polarized dermoscopic, and one non-polarized dermoscopic).<br>Procedure: Skin biopsy<br>* A skin biopsy is a small procedure that removes a sample of skin from the surface of the body. The method utilized will be either a shave or punch technique. The maximum size of a punch biopsy will be 6mm and these wounds are generally closed with no more than 2-3 sutures. A skin biopsy takes <15 minutes including preparation time, administration of intradermal anesthesia using lidocaine 1% with epinephrine 1:100,000, removal of the skin sample, achievement of hemostasis, dressing the wound, and providing instructions for home care. Samples will be placed formalin for routine processing.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Agreement Between Telemedicine and In-Person Treatment Recommendation | To determine the agreement between in-person recommendation and the telemedicine (tele) recommendation, the number of discordant benign vs. malignant diagnoses will be calculated; specifically, the number of subjects that were recommended a biopsy from the in-person dermatologist but were recommended no biopsy from the teledermatology team, and the number of subjects that were recommended no biopsy from the in-person dermatologist but biopsy by the teledermatologist team. | End of the study (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer | Assessment of the dermatologist's ability to designate an individual who has skin cancer as positive using the telemedicine platform. | End of the study (4 weeks) | 
| Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer | Assessment of the dermatologist's ability to designate an individual who has skin cancer as positive during in-person evaluations. | End of the study (4 weeks) | 
| Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer | Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as negative using the telemedicine platform. | End of the study (4 weeks) | 
| Specificity of In-Person Evaluation in Diagnosing Skin Cancer | Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as negative during in-person evaluations. | End of the study (4 weeks) | 
| False-Positive Rate of Telemedicine Evaluation | The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of telemedicine evaluations. | End of the study (4 weeks) | 
| False-Positive Rate of In-Person Evaluation | The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of in-person evaluations. | End of the study (4 weeks) | 
| False-Negative Rate of Telemedicine Evaluation | The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of telemedicine evaluations. | End of the study (4 weeks) | 
| False-Negative Rate of In-Person Evaluation | The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of in-person evaluations. | End of the study (4 weeks) | 
| Positive Predictive Value of Telemedicine Evaluation | The probability that a patient with a positive (abnormal) test result via telemedicine evaluation actually has skin cancer. | End of the study (4 weeks) | 
| Positive Predictive Value of In-Person Evaluation | The probability that a patient with a positive (abnormal) test result via in-person evaluation actually has skin cancer. | End of the study (4 weeks) | 
| Negative Predictive Value of Telemedicine Evaluation | The probability that a person with a negative (normal) test result via telemedicine evaluation is truly free of disease. | End of the study (4 weeks) | 
| Negative Predictive Value of In-Person Evaluation | The probability that a person with a negative (normal) test result via in-person evaluation is truly free of disease. | End of the study (4 weeks) |