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.
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. DermDx is a deep learning-based algorithm that analyzes lesion images to detect skin cancer. The software does not have dedicated hardware and can accept as input any dermoscopic images taken with commercial dermoscopes. Because the study is designed to investigate the change in the performance of the PCPs before and after seeing the device output, a single-arm study design has been used.
Study Type
OBSERVATIONAL
Enrollment
81
DermDx is a computer-aided diagnosis (CADx) software product that uses an AI-based algorithm to evaluate non-invasively captured images of skin lesions obtained from any commercially available dermoscopes. DermDx uses state-of-the-art deep neural network models that have been trained on a large database of dermoscopy images. DermDx analyzes the image of a new skin lesion and provides an output.
Remote
North Augusta, South Carolina, United States
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.
Time frame: 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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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
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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.
Time frame: 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.
Time frame: 6 months