Deep Neural Networks on the Accuracy of Skin Disease Diagnosis in Non-Dermatologists

Skin Diseases Clinical Trial

Official title:

Effect of Using Deep Neural Networks on the Accuracy of Skin Disease Diagnosis in Non-Dermatologist Physician

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04636164
• Other study ID #: 2020-3233
• Status: Terminated
• Phase: N/A
• Start date: November 27, 2020
• Est. completion date: December 27, 2021

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Deep neural networks (DNN) has been applied to many kinds of skin diseases in experimental settings.

Objective: The objective of this study is to confirm the augmentation of deep neural networks for the diagnosis of skin diseases in non-dermatologist physicians in a real-world setting.

Methods: A total of 40 non-dermatologist physicians in a single tertiary care hospital will be enrolled. They will be randomized to a DNN group and control group. By comparing two groups, the investigators will estimate the effect of using deep neural networks on the diagnosis of skin disease in terms of accuracy.

Description:

In the DNN group and control group, these steps are the same process.

1. Routine exam and capture photographs of skin lesions for all eligible consecutive series patient.

2. Make a clinical diagnosis (BEFORE-DX)

3. Make a clinical diagnosis (AFTER-DX)

4. consult to dermatologist

In the DNN group, after making the BEFORE-DX, physicians use deep neural networks and make an AFTER-DX considering the results of the deep neural networks (Model Dermatology, build 2020).

In the control group, after making the BEFORE-DX, physicians make an AFTER-DX after reviewing the pictures of skin lesions once more.

Ground truth will be based on the biopsy if available, or the consensus diagnosis of the dermatologists.

The investigators will compare the accuracy between the DNN group and control group after 6 consecutive months study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: December 27, 2021
• Est. primary completion date: November 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• non-dermatologist physician (residents) who agree to participate in this study

Exclusion Criteria:

• dermatology residents

• non-dermatology residents who use other deep neural networks for skin lesion diagnosis

Related Conditions & MeSH terms

• Skin Diseases

Intervention

Diagnostic Test:
• Model Dermatology (deep neural networks; Build 2020)
Physicians in the DNN group take pictures of the skin lesion and use the algorithm by uploading pictures.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pyoeng Gyun Choe

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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Han SS, Park I, Eun Chang S, Lim W, Kim MS, Park GH, Chae JB, Huh CH, Na JI. Augmented Intelligence Dermatology: Deep Neural Networks Empower Medical Professionals in Diagnosing Skin Cancer and Predicting Treatment Options for 134 Skin Disorders. J Invest Dermatol. 2020 Sep;140(9):1753-1761. doi: 10.1016/j.jid.2020.01.019. Epub 2020 Mar 31. — View Citation

Lin H, Li R, Liu Z, Chen J, Yang Y, Chen H, Lin Z, Lai W, Long E, Wu X, Lin D, Zhu Y, Chen C, Wu D, Yu T, Cao Q, Li X, Li J, Li W, Wang J, Yang M, Hu H, Zhang L, Yu Y, Chen X, Hu J, Zhu K, Jiang S, Huang Y, Tan G, Huang J, Lin X, Zhang X, Luo L, Liu Y, Liu X, Cheng B, Zheng D, Wu M, Chen W, Liu Y. Diagnostic Efficacy and Therapeutic Decision-making Capacity of an Artificial Intelligence Platform for Childhood Cataracts in Eye Clinics: A Multicentre Randomized Controlled Trial. EClinicalMedicine. 2019 Mar 17;9:52-59. doi: 10.1016/j.eclinm.2019.03.001. eCollection 2019 Mar. — View Citation

Liu Y, Jain A, Eng C, Way DH, Lee K, Bui P, Kanada K, de Oliveira Marinho G, Gallegos J, Gabriele S, Gupta V, Singh N, Natarajan V, Hofmann-Wellenhof R, Corrado GS, Peng LH, Webster DR, Ai D, Huang SJ, Liu Y, Dunn RC, Coz D. A deep learning system for differential diagnosis of skin diseases. Nat Med. 2020 Jun;26(6):900-908. doi: 10.1038/s41591-020-0842-3. Epub 2020 May 18. — View Citation

Sellheyer K, Bergfeld WF. A retrospective biopsy study of the clinical diagnostic accuracy of common skin diseases by different specialties compared with dermatology. J Am Acad Dermatol. 2005 May;52(5):823-30. — 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

Wang P, Liu X, Berzin TM, Glissen Brown JR, Liu P, Zhou C, Lei L, Li L, Guo Z, Lei S, Xiong F, Wang H, Song Y, Pan Y, Zhou G. Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):343-351. doi: 10.1016/S2468-1253(19)30411-X. Epub 2020 Jan 22. Erratum in: Lancet Gastroenterol Hepatol. 2020 Apr;5(4):e3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Top-1 diagnostic accuracy	frequency of correct Top-1 prediction	6 consecutive months
Secondary	Top-2 and 3 diagnostic accuracy	frequency of correct Top-2 and 3 prediction	6 consecutive months
Secondary	Infection sensitivity	positive rate of infection diagnosis	6 consecutive months
Secondary	Malignancy sensitivity	Positive rate of malignancy diagnosis	6 consecutive months