UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039480 |
|---|---|
| Receipt number | R000045015 |
| Scientific Title | TOMORROW registry for IgG4-related disease |
| Date of disclosure of the study information | 2020/02/14 |
| Last modified on | 2024/02/16 10:03:48 |
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Basic information
Public title
Development of patient database for IgG4-related disease, and analysis of clinical data and samples
Acronym
Database for IgG4-related disease, TOMORROW registry
Scientific Title
TOMORROW registry for IgG4-related disease
Scientific Title:Acronym
TOMORROW registry for IgG4-related disease
Region
| Japan |
Condition
Condition
IgG4-related disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Nephrology | Clinical immunology |
| Ophthalmology | Oto-rhino-laryngology | Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish a database for IgG4-related disease and resolve clinical unmet needs in the practice
Basic objectives2
Others
Basic objectives -Others
To explore novel treatment for precision medicine
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To establish a database for IgG4-related disease and resolve clinical unmet needs in the practice
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with IgG4-related disease, diagnosed by the diagnostic criteria for IgG4-related disease, 2011
Key exclusion criteria
None
Target sample size
100
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
Department of Rheumatology and Allergy, 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
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment period may be extended
Management information
Registered date
| 2020 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045015
