UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039481 |
|---|---|
| Receipt number | R000045017 |
| Scientific Title | Development of a new diagnostic method for IgG4-related diseases based on machine learning |
| Date of disclosure of the study information | 2020/02/14 |
| Last modified on | 2022/08/17 10:21:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mocha@ims.u-tokyo.ac.jp
Sponsor or person
Institute
The Institute of Medical Science, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045017
