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Completed

NCT Number: NCT04411810

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

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.

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Key information

Conditions

Skin Cancer Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nevisense 3.0

Device

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.

Dermlite Cam

Device

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). NOTE - for the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam.

skin biopsy

Procedure

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.

Barco Demetra

Device

Barco Demetra is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin which can then be stored, retrieved, displayed, and reviewed by medical practitioners. The Barco Demetra received 510(k) Premarket approval (K192829). The system involves a hardware imaging device and a stand-alone software application. The hardware device is a portable, battery-powered medical device for acquiring and visualizing images of the skin and uploads all images to cloud storage. The software application is cloud software with an associated web application; it can be used to visualize images and related data and can generate consultation reports. For the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam.

Primary outcomes

  1. Accuracy of Skin Cancer Diagnosis: In-Person Assessment

    Time frame: 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.

  2. Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense

    Time frame: 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.

  3. Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense

    Time frame: 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 outcomes

  1. Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense

    Time frame: 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.

  2. Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense

    Time frame: 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.

  3. Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer

    Time frame: 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.

  4. Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense

    Time frame: 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.

  5. Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense

    Time frame: 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.

  6. Specificity of In-Person Evaluation in Diagnosing Skin Cancer

    Time frame: 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.

  7. False-Positive Rate of Telemedicine Evaluation: Without Nevisense

    Time frame: 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.

  8. False-Positive Rate of Telemedicine Evaluation: With Nevisense

    Time frame: 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.

  9. False-Positive Rate of In-Person Evaluation

    Time frame: 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.

  10. False-Negative Rate of Telemedicine Evaluation: Without Nevisense

    Time frame: 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.

  11. False-Negative Rate of Telemedicine Evaluation: With Nevisense

    Time frame: 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.

  12. False-Negative Rate of In-Person Evaluation

    Time frame: 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.

  13. Positive Predictive Value of Telemedicine Evaluation: Without Nevisense

    Time frame: 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.

  14. Positive Predictive Value of Telemedicine Evaluation: With Nevisense

    Time frame: 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.

  15. Positive Predictive Value of In-Person Evaluation

    Time frame: 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.

  16. Negative Predictive Value of Telemedicine Evaluation: Without Nevisense

    Time frame: 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.

  17. Negative Predictive Value of Telemedicine Evaluation: With Nevisense

    Time frame: 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.

  18. Negative Predictive Value of In-Person Evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2020
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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