UMIN-CTR Clinical Trial

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