Clinical trial NCT06463860: Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers
Official title: Retrospective, Multi-Center Study to Evaluate the Performance of DermDx as an Adjunctive Tool for Primary Care Physicians in the Detection of Skin Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer
Keywords: Lesions
Artificial Intelligence
Skin Cancer
Malignant Lesions
Benign Lesions
Lead sponsor: MetaOptima Technology Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be selected from patients with lesions suspected of skin cancer

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* The subjects must be Primary Care Physicians who are board certified in family medicine or internal medicine.

Exclusion criteria:

* Subjects not meeting inclusion criteria.

Primary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: Diagnostic specificity of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
measure: 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.
timeFrame: 6 months
Locations:
city: N. Augusta
country: United States
facility: Remote
state: South Carolina
Study officials:
affiliation: MetaOptima Technology Inc.
name: Majid Razmara, PhD
role: STUDY_CHAIR
References:
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