Trial Outcomes & Findings for SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer (NCT NCT04411810)
NCT ID: NCT04411810
Last Updated: 2024-04-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
End of the study (4 weeks)
Results posted on
2024-04-08
Participant Flow
Unit of analysis: Skin lesions
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
149 378
|
|
Overall Study
Participants Completed Telemedicine Evaluation Visit
|
148 377
|
|
Overall Study
Participants Completed In-Person Evaluation Visit
|
148 377
|
|
Overall Study
COMPLETED
|
147 375
|
|
Overall Study
NOT COMPLETED
|
2 3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Screen failure
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
Baseline characteristics by cohort
| Measure |
Participants With Skin Lesions
n=147 Participants
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.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
147 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Accuracy of Skin Cancer Diagnosis: In-Person Assessment
|
93 percentage of skin lesions
Interval 90.0 to 95.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense
|
91 percentage of skin lesions
Interval 88.0 to 93.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense
|
83 percentage of skin lesions
Interval 79.0 to 87.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense
|
85 percentage of skin lesions
Interval 57.0 to 97.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense
|
92 percentage of skin lesions
Interval 65.0 to 100.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer
|
85 percentage of skin lesions
Interval 57.0 to 97.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense
|
91 percentage of skin lesions
Interval 88.0 to 94.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense
|
83 percentage of skin lesions
Interval 79.0 to 86.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Specificity of In-Person Evaluation in Diagnosing Skin Cancer
|
93 percentage of skin lesions
Interval 90.0 to 95.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
False-Positive Rate of Telemedicine Evaluation: Without Nevisense
|
9 percentage of skin lesions
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
False-Positive Rate of Telemedicine Evaluation: With Nevisense
|
17 percentage of skin lesions
Interval 13.0 to 21.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
False-Positive Rate of In-Person Evaluation
|
7 percentage of skin lesions
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
False-Negative Rate of Telemedicine Evaluation: Without Nevisense
|
1 percentage of skin lesions
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
False-Negative Rate of Telemedicine Evaluation: With Nevisense
|
0 percentage of skin lesions
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
False-Negative Rate of In-Person Evaluation
|
1 percentage of skin lesions
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Positive Predictive Value of Telemedicine Evaluation: Without Nevisense
|
26 percentage of skin lesions
Interval 15.0 to 40.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Positive Predictive Value of Telemedicine Evaluation: With Nevisense
|
16 percentage of skin lesions
Interval 9.0 to 26.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Positive Predictive Value of In-Person Evaluation
|
31 percentage of skin lesions
Interval 18.0 to 47.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Negative Predictive Value of Telemedicine Evaluation: Without Nevisense
|
99 percentage of skin lesions
Interval 98.0 to 100.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Negative Predictive Value of Telemedicine Evaluation: With Nevisense
|
100 percentage of skin lesions
Interval 98.0 to 100.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Skin Lesions
n=375 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.
|
|---|---|
|
Negative Predictive Value of In-Person Evaluation
|
99 percentage of skin lesions
Interval 98.0 to 100.0
|
Adverse Events
Participants With Skin Lesions
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Skin Lesions
n=147 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Minor skin infection
|
0.68%
1/147 • 4 months
Non-systematic - patient self-report
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place