Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers

December 15, 2024 updated by: MetaOptima Technology Inc.

Retrospective, Multi-Center Study to Evaluate the Performance of DermDx as an Adjunctive Tool for Primary Care Physicians in the Detection of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • N. Augusta, South Carolina, United States, 29860
        • Remote

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population will be selected from patients with lesions suspected of skin cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Double reading of all cases with and without software output
Device: DermDx
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 6 months
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
Time Frame: 6 months
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

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 months
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.
Time Frame: 6 months
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
Time Frame: 6 months
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.
Time Frame: 6 months
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

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetaOptima Technology Inc.

Investigators

  • Study Chair: Majid Razmara, PhD, MetaOptima Technology Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2024

Primary Completion (Actual)

November 27, 2024

Study Completion (Actual)

November 27, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 15, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Real-Dx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study protocol, documentation, data, and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorized third party without prior written approval of the sponsor. Cases will be assigned with a unique case identifier, which will be visible on each image and clinical information pertaining to the case, for tracking purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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