UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041161 |
|---|---|
| Receipt number | R000046452 |
| Scientific Title | Research on the integration and promotion of utilization of extensive information covering a wide variety of rare diseases through the development of comprehensive information infrastructure |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2020/07/20 14:14:07 |
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Basic information
Public title
Research on the integration and promotion of utilization of extensive information covering a wide variety of rare diseases through the development of comprehensive information infrastructure
Acronym
RADDAR-J(National platform for Rare Diseases Data Registry of Japan)
Scientific Title
Research on the integration and promotion of utilization of extensive information covering a wide variety of rare diseases through the development of comprehensive information infrastructure
Scientific Title:Acronym
RADDAR-J(National platform for Rare Diseases Data Registry of Japan)
Region
| Japan |
Condition
Condition
Rare Diseases
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Ophthalmology | Dermatology |
| Psychiatry | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology | Oral surgery |
| Neurosurgery | Cardiovascular surgery | Laboratory medicine |
| Operative medicine | Emergency medicine | Blood transfusion |
| Intensive care medicine | Dental medicine | Adult |
| Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will develop and implement a registry system which accumulates and integrate genome/omics and clinical information of a variety of rare diseases, and construct a prototype of a large information basis for rare disease research. We will also contribute to the promotion of rare disease research through the redefinition of disease concepts by analysis of accumulated information with artificial intelligence (AI), and by the establishment of genomic/omics analysis using cutting-edge technologies leading to the analytical models for diagnostic support.
Basic objectives2
Others
Basic objectives -Others
It depends on the research content of the research group which uses this platform.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It depends on the research content of the research group which uses this platform.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Criteria depends on that defined by each research group collaborated with this research
Key exclusion criteria
Criteria depends on that defined by each research group collaborated with this research
Target sample size
1000000
Research contact person
Name of lead principal investigator
| 1st name | Fumihiko |
| Middle name | |
| Last name | Matsuda |
Organization
Kyoto University Graduate school of Medicine
Division name
Center for Genomic Medicine
Zip code
606-8507
Address
Shogoin Kawahara-cho 53, Sakyo-ku, 606-8507 Kyoto
TEL
075-751-4157
fumi@genome.med.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kyoto University Graduate school of Medicine
Division name
Center for Genomic Medicine
Zip code
606-8507
Address
Shogoin Kawahara-cho 53, Sakyo-ku, 606-8507 Kyoto
TEL
075-751-4157
Homepage URL
yamaguchi@genome.med.kyoto-u.ac.jp
Sponsor or person
Institute
Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Agency for Medical Research and Development
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
kenkyuhan ni izonsuru
Org. issuing International ID_1
it depends
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 | 07 | Month | 20 | 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
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | 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
Registered items are defined by each research group collaborated with this research.
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2020 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046452
