Deep Neural Networks on the Accuracy of Skin Disease Diagnosis in Non-Dermatologists
Primary Purpose
Skin Diseases
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Model Dermatology (deep neural networks; Build 2020)
Sponsored by
About this trial
This is an interventional diagnostic trial for Skin Diseases focused on measuring skin diseases, deep neural networks
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DNN group
Control group
Arm Description
using deep neural networks for skin lesion diagnosis
conventional diagnosis
Outcomes
Primary Outcome Measures
Top-1 diagnostic accuracy
frequency of correct Top-1 prediction
Secondary Outcome Measures
Top-2 and 3 diagnostic accuracy
frequency of correct Top-2 and 3 prediction
Infection sensitivity
positive rate of infection diagnosis
Malignancy sensitivity
Positive rate of malignancy diagnosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04636164
Brief Title
Deep Neural Networks on the Accuracy of Skin Disease Diagnosis in Non-Dermatologists
Official Title
Effect of Using Deep Neural Networks on the Accuracy of Skin Disease Diagnosis in Non-Dermatologist Physician
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
The rate of data collection was too slow.
Study Start Date
November 27, 2020 (Actual)
Primary Completion Date
November 27, 2021 (Actual)
Study Completion Date
December 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pyoeng Gyun Choe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
In the DNN group and control group, these steps are the same process.
Routine exam and capture photographs of skin lesions for all eligible consecutive series patient.
Make a clinical diagnosis (BEFORE-DX)
Make a clinical diagnosis (AFTER-DX)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases
Keywords
skin diseases, deep neural networks
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DNN group
Arm Type
Experimental
Arm Description
using deep neural networks for skin lesion diagnosis
Arm Title
Control group
Arm Type
No Intervention
Arm Description
conventional diagnosis
Intervention Type
Diagnostic Test
Intervention Name(s)
Model Dermatology (deep neural networks; Build 2020)
Intervention Description
Physicians in the DNN group take pictures of the skin lesion and use the algorithm by uploading pictures.
Primary Outcome Measure Information:
Title
Top-1 diagnostic accuracy
Description
frequency of correct Top-1 prediction
Time Frame
6 consecutive months
Secondary Outcome Measure Information:
Title
Top-2 and 3 diagnostic accuracy
Description
frequency of correct Top-2 and 3 prediction
Time Frame
6 consecutive months
Title
Infection sensitivity
Description
positive rate of infection diagnosis
Time Frame
6 consecutive months
Title
Malignancy sensitivity
Description
Positive rate of malignancy diagnosis
Time Frame
6 consecutive months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31981517
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.
Results Reference
background
PubMed Identifier
31143882
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.
Results Reference
background
PubMed Identifier
32424212
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.
Results Reference
background
PubMed Identifier
32243882
Citation
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.
Results Reference
background
PubMed Identifier
15858472
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. doi: 10.1016/j.jaad.2004.11.072.
Results Reference
background
PubMed Identifier
31255749
Citation
Cui X, Wei R, Gong L, Qi R, Zhao Z, Chen H, Song K, Abdulrahman AAA, Wang Y, Chen JZS, Chen S, Zhao Y, Gao X. Assessing the effectiveness of artificial intelligence methods for melanoma: A retrospective review. J Am Acad Dermatol. 2019 Nov;81(5):1176-1180. doi: 10.1016/j.jaad.2019.06.042. Epub 2019 Jun 27.
Results Reference
background
PubMed Identifier
31201137
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.
Results Reference
background
Learn more about this trial
Deep Neural Networks on the Accuracy of Skin Disease Diagnosis in Non-Dermatologists
We'll reach out to this number within 24 hrs