UMIN-CTR Clinical Trial

Basic information
Public title	Development of a new diagnostic method for IgG4-related diseases based on machine learning
Acronym	Development of a new diagnostic method for IgG4-related diseases based on machine learning
Scientific Title	Development of a new diagnostic method for IgG4-related diseases based on machine learning
Scientific Title:Acronym	Development of a new diagnostic method for IgG4-related diseases based on machine learning
Region	Japan

Condition
Condition	IgG4-related disease
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Pneumology Nephrology Clinical immunology Ophthalmology Oto-rhino-laryngology Urology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish an algorithm that can efficiently predict the evaluation of systemic organ involvements using validation data.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To establish an algorithm that can efficiently predict the evaluation of systemic organ involvements using validation data.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with IgG4-related disease, other rheumatic and gastroenterologic disorders and healthy controls
Key exclusion criteria	None
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Motohisa Middle name Last name YAMAMOTO
Organization	The Institute of Medical Science, The University of Tokyo
Division name	Division of Rheumatology, Center for Vaccine and Antibody, IMSUT Hospital
Zip code	108-8639
Address	4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL	03-3443-8111
Email	mocha@ims.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Motohisa Middle name Last name YAMAMOTO
Organization	The Institute of Medical Science, The University of Tokyo
Division name	Division of Rheumatology, Center for Vaccine and Antibody, IMSUT Hospital
Zip code	108-8639
Address	4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL	03-3443-8111
Homepage URL
Email	mocha@ims.u-tokyo.ac.jp

Sponsor
Institute	The Institute of Medical Science, The University of Tokyo
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Office of Reseach Ethics, The Institute of Medical Science, The University of Tokyo
Address	4-6-1, Shirokanedai, Minato-ku, Tokyo
Tel	03-3443-8111
Email	ken-rin@ims.u-tokyo.ac.jp

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 14 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
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	2019 Year 07 Month 18 Day
Date of IRB	2019 Year 11 Month 21 Day
Anticipated trial start date	2019 Year 11 Month 22 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Completed

Management information
Registered date	2020 Year 02 Month 14 Day
Last modified on	2022 Year 08 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045017