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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039371
Receipt No. R000044893
Scientific Title Study of convolutional neural network for classification of two-dimensional array images generated by clinical information in rheumatoid arthritis
Date of disclosure of the study information 2020/02/10
Last modified on 2020/04/03

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Basic information
Public title Study of artificial intelligence to diagnose rheumatoid arthritis
Acronym Study of artificial intelligence to diagnose rheumatoid arthritis
Scientific Title Study of convolutional neural network for classification of two-dimensional array images generated by clinical information in rheumatoid arthritis
Scientific Title:Acronym Study of convolutional neural network to diagnose rheumatoid arthritis
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This research aimed to study use of convolutional neural network (CNN) for diagnosis of rheumatoid arthritis (RA).
Basic objectives2 Others
Basic objectives -Others Ability to diagnose rheumatoid arthritis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We semi-quantitatively converted several clinical information obtained from first visit in hospital to four color square images and arranged them as one image. Some modifications were added to clinical information in each patient to increase tuning data. These were used to fine-tune one of the pretrained CNNs, AlexNet. The fine-tuned AlexNet classified testing images that were independent of the tuning data.
Key secondary outcomes We compared the classification ability of the CNN and diagnosis of rheumatologists.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria In this study, undiagnosed patients with arthralgia in their fingers or wrists who first visited hospital during 1 January to 31 May 2019 were enrolled.
Key exclusion criteria The study outline was published on the hospital's homepag and an opt-out management strategy was used to collect the patient information. Patients who did not hope to participate in were excluded. Patients judged by doctors to be inappropriate for the study were excluded.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Fukae
Organization Hokkaido Medical Center for Rheumatic Diseases
Division name Rheumatology
Zip code 063-0811
Address 1-45 3-Chome, 1-Jo, Kotoni, Nishi-ku, Sapporo 063-0811, Japan.
TEL 81-11-611-1373
Email jun.fukae@ryumachi-jp.com

Public contact
Name of contact person
1st name Jun
Middle name
Last name Fukae
Organization Hokkaido Medical Center for Rheumatic Diseases
Division name Rheumatology
Zip code 063-0811
Address 1-45 3-Chome, 1-Jo, Kotoni, Nishi-ku, Sapporo 063-0811, Japan.
TEL 81-11-611-1373
Homepage URL http://www.ra-hp.jp/clinical_research.html
Email jun.fukae@ryumachi-jp.com

Sponsor
Institute Hokkaido Medical Center for Rheumatic Diseases
Institute
Department

Funding Source
Organization Hokkaido Medical Center for Rheumatic Diseases
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Local ethics committees of Hokkaido Medical Center for Rheumatic Diseases
Address 1-45 3-Chome, 1-Jo, Kotoni, Nishi-ku, Sapporo 063-0811, Japan.
Tel 81-11-611-1373
Email jun.fukae@ryumachi-jp.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/s41598-020-62634-3
Number of participants that the trial has enrolled 249
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
2019 Year 03 Month 19 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study was retrospective study. We collected patients data (01,Jan-31,May,2019) based on records. The data collecting and analyswas started from 01,Oct,2019.

Management information
Registered date
2020 Year 02 Month 03 Day
Last modified on
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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