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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
Pyoeng Gyun Choe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Skin Diseases focused on measuring skin diseases, deep neural networks

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 13, 2020
Last Updated
October 25, 2022
Sponsor
Pyoeng Gyun Choe
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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:
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31981517
Citation
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Deep Neural Networks on the Accuracy of Skin Disease Diagnosis in Non-Dermatologists

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