UMIN-CTR Clinical Trial

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
Email	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
Email	takeuchi@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052407