UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054321
Receipt number R000061975
Scientific Title Study of artificial intelligence for classification of joint ultrasound images in rheumatoid arthritis
Date of disclosure of the study information 2024/07/05
Last modified on 2024/11/04 09:31:13

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Basic information

Public title

Study of artificial intelligence in rheumatoid arthritis

Acronym

Study of artificial intelligence in rheumatoid arthritis

Scientific Title

Study of artificial intelligence for classification of joint ultrasound images in rheumatoid arthritis

Scientific Title:Acronym

Study of convolutional neural network for joint ultrasound images in 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 convolutional neural network (CNN) to classify joint ultrasound images in rheumatoid arthritis.

Basic objectives2

Others

Basic objectives -Others

To study performance of CNN to classify synovial vascularity of joint ultrasonography in rheumatoid arthritis.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We created artificial joint ultrasound images for CNN training. We studied classification performance of pre-trained CNNs with transfer learning by the artificial images.

Key secondary outcomes



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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with rheumatoid arthritis who had joint ultrasonography examination in our hospital were enrolled.

Key exclusion criteria

The study outline was shown in the hospital's homepage 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

100


Research contact person

Name of lead principal investigator

1st name Jun
Middle name
Last name Fukae

Organization

Kuriyama Red Cross Hospital

Division name

Rheumatology

Zip code

069-1513

Address

3-2, Asahi, Kuriyama chou, Yubari gun, Hokkaido, 069-1513, Japan

TEL

81-123-72-1015

Email

jun.fukae@ryumachi-jp.com


Public contact

Name of contact person

1st name Jun
Middle name
Last name Fukae

Organization

Kuriyama Red Cross Hospital

Division name

Rheumatology

Zip code

069-1513

Address

3-2, Asahi, Kuriyama chou, Yubari gun, Hokkaido, 069-1513, Japan

TEL

81-123-72-1015

Homepage URL


Email

jun.fukae@ryumachi-jp.com


Sponsor or person

Institute

Kuriyama Red Cross Hospital, Rheumatology, Jun Fukae

Institute

Department

Personal name



Funding Source

Organization

Kuriyama Red Cross Hospital, Rheumatology, Jun Fukae

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 Kuriyama Red Cross Hospital

Address

3-2, Asahi, Kuriyama chou, Yubari gun, Hokkaido, 069-1513, Japan

Tel

81-123-72-1015

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

2024 Year 07 Month 05 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

74

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

2024 Year 04 Month 20 Day

Date of IRB

2024 Year 04 Month 26 Day

Anticipated trial start date

2024 Year 05 Month 01 Day

Last follow-up date

2024 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2024 Year 09 Month 01 Day

Date analysis concluded

2024 Year 09 Month 01 Day


Other

Other related information

This was observational study. We collected data of patients with rheumatoid arthritis who had joint ultrasonography at our hospital in the past or study period.


Management information

Registered date

2024 Year 05 Month 06 Day

Last modified on

2024 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061975


Research Plan
Registered date File name
2024/09/05 Research Protocol.docx

Research case data specifications
Registered date File name
2024/09/05 Research Data.docx

Research case data
Registered date File name
2024/09/05 Training data.zip