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

Skin Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463860
• Other study ID #: Real-Dx
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: MetaOptima Technology Inc.
• Contact: Majid Razmara, PhD
• Phone: 778-328-1949
• Email: majid[@]metaoptima.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MetaOptima Technology Inc.

References & Publications (17)

Armstrong BK, Kricker A. The epidemiology of UV induced skin cancer. J Photochem Photobiol B. 2001 Oct;63(1-3):8-18. doi: 10.1016/s1011-1344(01)00198-1. — View Citation

Carlson JA. Tumor doubling time of cutaneous melanoma and its metastasis. Am J Dermatopathol. 2003 Aug;25(4):291-9. doi: 10.1097/00000372-200308000-00003. — View Citation

Ehrlich A, Kostecki J, Olkaba H. Trends in dermatology practices and the implications for the workforce. J Am Acad Dermatol. 2017 Oct;77(4):746-752. doi: 10.1016/j.jaad.2017.06.030. Epub 2017 Aug 4. — View Citation

Feng H, Berk-Krauss J, Feng PW, Stein JA. Comparison of Dermatologist Density Between Urban and Rural Counties in the United States. JAMA Dermatol. 2018 Nov 1;154(11):1265-1271. doi: 10.1001/jamadermatol.2018.3022. — View Citation

Glazer AM, Farberg AS, Winkelmann RR, Rigel DS. Analysis of Trends in Geographic Distribution and Density of US Dermatologists. JAMA Dermatol. 2017 Apr 1;153(4):322-325. doi: 10.1001/jamadermatol.2016.5411. No abstract available. — View Citation

Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. — View Citation

Hajdarevic S, Hornsten A, Sundbom E, Isaksson U, Schmitt-Egenolf M. Health-care delay in malignant melanoma: various pathways to diagnosis and treatment. Dermatol Res Pract. 2014;2014:294287. doi: 10.1155/2014/294287. Epub 2014 Jan 5. — View Citation

Jaklitsch E, Thames T, de Campos Silva T, Coll P, Oliviero M, Ferris LK. Clinical Utility of an AI-powered, Handheld Elastic Scattering Spectroscopy Device on the Diagnosis and Management of Skin Cancer by Primary Care Physicians. J Prim Care Community Health. 2023 Jan-Dec;14:21501319231205979. doi: 10.1177/21501319231205979. — View Citation

Katragadda C, Finnane A, Soyer HP, Marghoob AA, Halpern A, Malvehy J, Kittler H, Hofmann-Wellenhof R, Da Silva D, Abraham I, Curiel-Lewandrowski C; International Society of Digital Imaging of the Skin (ISDIS)-International Skin Imaging Collaboration (ISIC) Group. Technique Standards for Skin Lesion Imaging: A Delphi Consensus Statement. JAMA Dermatol. 2017 Feb 1;153(2):207-213. doi: 10.1001/jamadermatol.2016.3949. — View Citation

Lomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x. — View Citation

Madeja J, Kelsberg G, Safranek S. Does screening by primary care providers effectively detect melanoma and other skin cancers? J Fam Pract. 2020 Mar;69(2):E10-E12. No abstract available. — View Citation

Manolakos D, Patrick G, Geisse JK, Rabinovitz H, Buchanan K, Hoang P, Rodriguez-Diaz E, Bigio IJ, Cognetta AB. Use of an elastic-scattering spectroscopy and artificial intelligence device in the assessment of lesions suggestive of skin cancer: A comparative effectiveness study. JAAD Int. 2023 Oct 11;14:52-58. doi: 10.1016/j.jdin.2023.08.019. eCollection 2024 Mar. — View Citation

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. — View Citation

Roetzheim RG, Lee JH, Ferrante JM, Gonzalez EC, Chen R, Fisher KJ, Love-Jackson K, McCarthy EP. The influence of dermatologist and primary care physician visits on melanoma outcomes among Medicare beneficiaries. J Am Board Fam Med. 2013 Nov-Dec;26(6):637-47. doi: 10.3122/jabfm.2013.06.130042. — View Citation

Rogers HW, Weinstock MA, Harris AR, Hinckley MR, Feldman SR, Fleischer AB, Coldiron BM. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol. 2010 Mar;146(3):283-7. doi: 10.1001/archdermatol.2010.19. — View Citation

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. — View Citation

US Department of Health and Human Services. The Surgeon General's Call to Action to Prevent Skin Cancer. Washington (DC): Office of the Surgeon General (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK247172/ — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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