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

NCT06463860 | Completed FDA Device

• 1 other identifier: Real-Dx
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Cancer

Keywords

Lesions; Artificial Intelligence; Skin Cancer; Malignant Lesions; Benign Lesions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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.

  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.

  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

  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.

  6 months

Other Outcomes (1)

• 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.

  6 months

Study Arms (1)

Double reading of all cases with and without software output

Double reading of all cases with and without software output

Device: DermDx

Interventions

DermDx DEVICE

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.

Double reading of all cases with and without software output

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• MetaOptima Technology Inc.: lead

Study Sites (1)

Remote

North Augusta, South Carolina, 29860, United States

Location

Related Publications (17)

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  PMID: 12876486 BACKGROUND

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  PMID: 24516469 BACKGROUND

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  PMID: 28784330 BACKGROUND

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  PMID: 30193349 BACKGROUND

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  PMID: 28146246 BACKGROUND

• Tschandl P, Codella N, Akay BN, Argenziano G, Braun RP, Cabo H, Gutman D, Halpern A, Helba B, Hofmann-Wellenhof R, Lallas A, Lapins J, Longo C, Malvehy J, Marchetti MA, Marghoob A, Menzies S, Oakley A, Paoli J, Puig S, Rinner C, Rosendahl C, Scope A, Sinz C, Soyer HP, Thomas L, Zalaudek I, Kittler H. Comparison of the accuracy of human readers versus machine-learning algorithms for pigmented skin lesion classification: an open, web-based, international, diagnostic study. Lancet Oncol. 2019 Jul;20(7):938-947. doi: 10.1016/S1470-2045(19)30333-X. Epub 2019 Jun 12.

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• Menzies SW, Sinz C, Menzies M, Lo SN, Yolland W, Lingohr J, Razmara M, Tschandl P, Guitera P, Scolyer RA, Boltz F, Borik-Heil L, Herbert Chan H, Chromy D, Coker DJ, Collgros H, Eghtedari M, Corral Forteza M, Forward E, Gallo B, Geisler S, Gibson M, Hampel A, Ho G, Junez L, Kienzl P, Martin A, Moloney FJ, Regio Pereira A, Ressler JM, Richter S, Silic K, Silly T, Skoll M, Tittes J, Weber P, Weninger W, Weiss D, Woo-Sampson P, Zilberg C, Kittler H. Comparison of humans versus mobile phone-powered artificial intelligence for the diagnosis and management of pigmented skin cancer in secondary care: a multicentre, prospective, diagnostic, clinical trial. Lancet Digit Health. 2023 Oct;5(10):e679-e691. doi: 10.1016/S2589-7500(23)00130-9.

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  PMID: 38143790 BACKGROUND

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Majid Razmara, PhD

  MetaOptima Technology Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 18, 2024
• Study Start: June 12, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)