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

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ClinicalTrials.gov Identifier: NCT04411810
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Skin Cancer Device: Nevisense 3.0 Device: Dermlite Cam Procedure: Skin biopsy Not Applicable

Detailed Description:
The purpose of this study is to see whether a teledermatologist can correctly diagnose skin cancer with the same accuracy as an in-person dermatologist. Telemedicine allows health care professionals to remotely evaluate, diagnose, and treat patients (i.e. without seeing you in person). A dermatologist who is not seeing the patient in person is called a teledermatologist. Currently, the standard of care, which means the accepted first choice of management, is an in-person evaluation. The telemedicine method that will use in this study is called 'store and forward'. This means the information will be sent to the teledermatologist after the patient leaves the clinic. The teledermatologist will use close-up photos and a device called Nevisense to make the diagnosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: David Polsky, MD, PhD 212-263-9087 David.Polsky@nyulangone.org
Contact: Susan Cataldo 212-263-5244 Susan.Cataldo@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: David Polsky, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: David Polsky, MD, PhD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04411810    
Other Study ID Numbers: 19-01242
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to David.Polsky@nyulangone.org To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases