UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039371 |
|---|---|
| Receipt number | 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 15:26:53 |
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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
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
jun.fukae@ryumachi-jp.com
Sponsor or person
Institute
Hokkaido Medical Center for Rheumatic Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044893
