SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 years of age or older
- •Have 1-3 lesions for evaluation
排除标准
- •Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear
研究组 & 干预措施
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.
干预措施: Barco Demetra (Device)
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.
干预措施: Nevisense 3.0 (Device)
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.
干预措施: Dermlite Cam (Device)
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.
干预措施: Skin biopsy (Procedure)
结局指标
主要结局
Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense(End of the study (4 weeks))
- False-Positive Rate of Telemedicine Evaluation: Without Nevisense(End of the study (4 weeks))
- Specificity of In-Person Evaluation in Diagnosing Skin Cancer(End of the study (4 weeks))
- False-Negative Rate of Telemedicine Evaluation: With Nevisense(End of the study (4 weeks))
- Positive Predictive Value of Telemedicine Evaluation: Without Nevisense(End of the study (4 weeks))
- Negative Predictive Value of In-Person Evaluation(End of the study (4 weeks))
- False-Negative Rate of Telemedicine Evaluation: Without Nevisense(End of the study (4 weeks))
- Positive Predictive Value of Telemedicine Evaluation: With Nevisense(End of the study (4 weeks))
- Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense(End of the study (4 weeks))
- False-Negative Rate of In-Person Evaluation(End of the study (4 weeks))
- Negative Predictive Value of Telemedicine Evaluation: Without Nevisense(End of the study (4 weeks))
- Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer(End of the study (4 weeks))
- Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense(End of the study (4 weeks))
- Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense(End of the study (4 weeks))
- False-Positive Rate of Telemedicine Evaluation: With Nevisense(End of the study (4 weeks))
- False-Positive Rate of In-Person Evaluation(End of the study (4 weeks))
- Positive Predictive Value of In-Person Evaluation(End of the study (4 weeks))
- Negative Predictive Value of Telemedicine Evaluation: With Nevisense(End of the study (4 weeks))