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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04411810

Enrollment

149

Registered

2020-06-02

Start date

2020-08-20

Completion date

2023-03-04

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer

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.

Interventions

DEVICENevisense 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.

DEVICEDermlite 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). 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.

PROCEDURESkin 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.

DEVICEBarco Demetra

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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 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: 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

Measure	Time frame	Description
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.
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-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.
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-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.
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.
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.
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.
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.
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: 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.
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.
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: 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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	147
Total	147

Arm

Count

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.

147

Total

147

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Screen failure	1
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Participants With Skin Lesions
Age, Continuous	65 years
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	121 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	7 Participants
Race (NIH/OMB) Black or African American	22 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants
Race (NIH/OMB) White	103 Participants
Region of Enrollment United States	147 participants
Sex: Female, Male Female	93 Participants
Sex: Female, Male Male	54 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 147
other Total, other adverse events	1 / 147
serious Total, serious adverse events	0 / 147

Outcome results

Primary

Accuracy of Skin Cancer Diagnosis: In-Person Assessment

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.