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

Not Applicable

Completed

• Conditions: Skin Cancer
• Interventions: Device: Nevisense 3.0; Device: Dermlite Cam; Procedure: Skin biopsy; Device: Barco Demetra

• Registration Number: NCT04411810
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Study Start: 2020-08-20
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-04
• Results First Submitted: 2024-03-04
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Results First Posted: 2024-04-08
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• Be 18 years of age or older
• Have 1-3 lesions for evaluation

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Exclusion Criteria

• Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with skin lesions	Dermlite Cam	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.
Participants with skin lesions	Barco Demetra	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.
Participants with skin lesions	Nevisense 3.0	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.
Participants with skin lesions	Skin biopsy	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense	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	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	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 Outcome Measures

Name	Time	Method
Specificity of In-Person Evaluation in Diagnosing Skin Cancer	End of the study (4 weeks)	Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" during in-person evaluations.
False-Negative Rate of Telemedicine Evaluation: With Nevisense	End of the study (4 weeks)	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 with Nevisense.
Positive Predictive Value of Telemedicine Evaluation: Without Nevisense	End of the study (4 weeks)	The probability that a patient with a positive (abnormal) test result via telemedicine evaluation without Nevisense actually has skin cancer.
Negative Predictive Value of In-Person Evaluation	End of the study (4 weeks)	The probability that a person with a negative (normal) test result via in-person evaluation is truly free of disease.
False-Negative Rate of Telemedicine Evaluation: Without Nevisense	End of the study (4 weeks)	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 without Nevisense.
Positive Predictive Value of Telemedicine Evaluation: With Nevisense	End of the study (4 weeks)	The probability that a patient with a positive (abnormal) test result via telemedicine evaluation with Nevisense actually has skin cancer.
Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense	End of the study (4 weeks)	Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" using the telemedicine platform without nevisense.
False-Negative Rate of In-Person Evaluation	End of the study (4 weeks)	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.
Negative Predictive Value of Telemedicine Evaluation: Without Nevisense	End of the study (4 weeks)	The probability that a person with a negative (normal) test result via telemedicine evaluation without Nevisense is truly free of disease.
Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense	End of the study (4 weeks)	Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" using the telemedicine platform with nevisense.
False-Positive Rate of Telemedicine Evaluation: Without Nevisense	End of the study (4 weeks)	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 without Nevisense.
Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer	End of the study (4 weeks)	Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" during in-person evaluations.
Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense	End of the study (4 weeks)	Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" using the telemedicine platform without nevisense.
Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense	End of the study (4 weeks)	Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" using the telemedicine platform with Nevisense.
False-Positive Rate of Telemedicine Evaluation: With Nevisense	End of the study (4 weeks)	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 with Nevisense.
False-Positive Rate of In-Person Evaluation	End of the study (4 weeks)	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.
Positive Predictive Value of In-Person Evaluation	End of the study (4 weeks)	The probability that a patient with a positive (abnormal) test result via in-person evaluation actually has skin cancer.
Negative Predictive Value of Telemedicine Evaluation: With Nevisense	End of the study (4 weeks)	The probability that a person with a negative (normal) test result via telemedicine evaluation with Nevisense is truly free of disease.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States