SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04411810|
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer||Device: Nevisense 3.0 Device: Dermlite Cam Procedure: Skin biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer|
|Actual Study Start Date :||August 20, 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||October 2022|
Experimental: Participants with skin lesions
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
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.
Device: Dermlite Cam
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).
Procedure: Skin biopsy
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.
- Percent of agreement between in person recommendation and telemedicine recommendation [ Time Frame: End of the study (4 weeks) ]To determine the agreement between in-person recommendation and the telemedicine (tele) recommendation the number of discordant benign vs. malignant diagnoses will be calculated. In particular, 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.
- Estimate the performance of the telemedicine system and in-person dermatologist in diagnosing skin cancer. [ Time Frame: End of the study (4 weeks) ]Specifically, the study will estimate the differences between the enhanced telemedicine diagnostic system and the in-person Dermatologist with respect to their sensitivities, specificities, positive predictive values and negative predictive values to diagnose histopathologically confirmed skin cancers.
- Impact on patient centered outcomes based on analysis of patient responses [ Time Frame: End of the study (4 weeks) ]Impact on patient centered outcomes based on analysis of patient responses collected on study self reported questionnaires
- Percentage of accuracy using Nevisense in diagnosis [ Time Frame: End of the study (4 weeks) ]Estimation of the number of lesions in which the information provided by the Nevisense score improves the accuracy and/or confidence of the teledermoscopists when compared to using solely the clinical and dermoscopic exam
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411810
|Contact: David Polsky, MD, PhD||212-263-9087||David.Polsky@nyulangone.org|
|Contact: Susan Cataldo||212-263-5244||Susan.Cataldo@nyulangone.org|
|United States, New York|
|NYU Langone Health||Recruiting|
|New York, New York, United States, 10016|
|Contact: David Polsky, MD|
|Principal Investigator:||David Polsky, MD, PhD||NYU Langone Health|