UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045914 |
|---|---|
| Receipt number | R000052407 |
| Scientific Title | Japanese National Registry for Behcet's Disease |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2021/10/29 10:18:46 |
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Basic information
Public title
Japanese National Registry for Behcet's Disease
Acronym
Japanese National Registry for Behcet's Disease
Scientific Title
Japanese National Registry for Behcet's Disease
Scientific Title:Acronym
Japanese National Registry for Behcet's Disease
Region
| Japan |
Condition
Condition
Behcet's disease
Classification by specialty
| Medicine in general | Gastroenterology | Neurology |
| Clinical immunology | Surgery in general | Gastrointestinal surgery |
| Vascular surgery | Pediatrics | Ophthalmology |
| Dermatology | Cardiovascular surgery | Adult |
| Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To collect clinical information on patients with Behcet's disease and to examine the endpoints in a sustained and long-term manner to elucidate the natural history and prognostic factors of Behcet's disease diagnosis, and to contribute to the revision of diagnostic criteria and guidelines for Behcet's disease diagnosis.
Basic objectives2
Others
Basic objectives -Others
Accumulation of clinical information on patients with Behcet's disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accumulation of medical information and genomic data of patients with Behcet's disease
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 | months-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with Behcet's disease or suspected to be suffering from Behcet's disease
Key exclusion criteria
Patients previously enrolled in this registry
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | Takeuchi |
| Last name | Mizuki |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
+81457872800
mizunobu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | Takeuchi |
| Last name | Takeuchi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
0457872800
Homepage URL
takeuchi@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
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
Yoshidakonoecho, Sakyo-ku, Kyoto
Tel
075-753-4680
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
| 2021 | Year | 10 | Month | 29 | 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
| 2021 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2041 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although the research period is permanent, ethical review approval and research permission will be obtained every five years.
Management information
Registered date
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052407
