Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers
NCT Number: NCT06463860
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Skin Cancer
Interventions: DEVICE: DermDx
Sponsor: MetaOptima Technology Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2024-12

Summary:
The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.

Primary Outcome Measures: The change in the diagnostic sensitivity of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer, The change in the diagnostic sensitivity of the PCPs with the use of DermDx results than without the use of DermDx results in the diagnosis of lesions suspicious of skin cancer, in comparison to the ground truth., 6 months|The change in the diagnostic accuracy of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer, The change in the Area Under the Curve for the diagnosis of skin cancer lesions by PCPs with the use of DermDx results than without the use of DermDx results, in comparison to the ground truth., 6 months
Secondary Outcome Measures: The change in sensitivity of management decision of the Primary Care Physicians (PCPs) with and without the use of DermDx in the management of lesions suspicious of skin cancer., The change in the sensitivity of the disease management decision of the PCPs with the use of DermDx results than without the use of DermDx results in the management of lesions suspicious of skin cancer, in comparison to the ground truth., 6 months|The accuracy of the disease management decision of the Primary Care Physicians (PCPs) with and without the use of DermDx in the management of lesions suspicious of skin cancer., The change in the Area Under the Curve (AUC) for the disease management decision of the PCPs with the use of DermDx results than without the use of DermDx results for lesions suspicious of skin cancer, in comparison to the ground truth., 6 months|Diagnostic specificity of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer, The diagnostic specificity of the PCPs with the use of DermDx results and without the use of DermDx results in the diagnosis of lesions suspicious of skin cancer, in comparison to the ground truth., 6 months|The specificity of the disease management decision of the Primary Care Physicians (PCPs) with and without the use of DermDx in the management of lesions suspicious of skin cancer., The specificity of the disease management decision of the PCPs with the use of DermDx results and without the use of DermDx results in the management of lesions suspicious of skin cancer, in comparison to the ground truth., 6 months
Other Outcome Measures: The mean change in the confidence of the Primary Care Practitioners (PCPs) in their management decision for benign and malignant lesions respectively, with and without the DermDx results., The mean change in the confidence of the PCPs in their management decision for benign and malignant lesions respectively, with and without DermDx results. This measure will show the mean change in confidence of the PCPs with and without the device for benign and malignant lesions respectively., 6 months