UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051848 |
|---|---|
| Receipt number | R000059077 |
| Scientific Title | Construction of genome research system for autoimmune diseases and research utilizing the registry |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2023/08/04 16:20:37 |
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Basic information
Public title
Construction of genome research system for autoimmune diseases and research utilizing the registry
Acronym
Construction of genome research system for autoimmune diseases and research utilizing the registry
Scientific Title
Construction of genome research system for autoimmune diseases and research utilizing the registry
Scientific Title:Acronym
Rare Disease Data Registry of Japan[60]
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus
Antiphospholipid syndrome
Polymyositis/Dermatomyositis
Mixed connective tissue disease
Sjogren's syndrome
Juvenile idiopathic arthritis
Adult Still's disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Nephrology | Neurology | Clinical immunology |
| Psychosomatic Internal Medicine | Infectious disease | Obstetrics and Gynecology |
| Pediatrics | Ophthalmology | Dermatology |
| Psychiatry | Orthopedics | Oral surgery |
| Dental medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
By collaborating with the "Construction of Rare Disease Data Registry of Japan for autoimmune disease, and long-term nationwide multi-institutional researches utilizing the registry", which accumulates the genomic information of the target autoimmune disease patients and accumulates the clinical information of the target disease patients, we will elucidate the natural history and prognostic factors of the target disease and contribute to the development and establishment of new treatment methods for the target disease in the future.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Pathogenic gene mutation
2) Germline mutations
3) Germline structural mutations
4) Germline copy number mutations
5) Somatic mutation
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who consented to "Construction of Rare Disease Data Registry of Japan for autoimmune disease, and long-term nationwide multi-institutional researches utilizing the registry"
2)Patients diagnosed with the autoimmune diseases according to the diagnostic criteria of the Ministry of Health, Labor and Welfare.
3)Patients who consented to participate in the study.
Key exclusion criteria
Patients judged to be inappropriate as a target by the judgment of researchers.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | SHIMIZU |
Organization
Tokyo Medical and Dental University Hospital
Division name
Pediatrics
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku Tokyo
TEL
03-5803-4677
autoimm-mhlw.lci@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | MORI |
Organization
Tokyo Medical and Dental University
Division name
Department of Lifetime Clinical Immunology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku Tokyo
TEL
03-5803-4677
Homepage URL
mori.phv@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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, JAPAN
Tel
075-753-4642
ethcom@kuhp.kyoto-u.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
| 2023 | Year | 08 | Month | 10 | 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
| 2022 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Be acquired at the same time in another study, the primary and secondary endpoints were observed every year for 10 years.
Management information
Registered date
| 2023 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059077
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
