UMIN-CTR Clinical Trial

Basic information
Public title	Subgroup classification of Behcet's Disease Based on clinical findings and genome-wide subtyping based on clinical findings and establishment of a national registry
Acronym	Establishment of a national registry for Behcet's disease
Scientific Title	Establishment of a national registry for Behcet's disease
Scientific Title:Acronym	Establishment of a national registry for Behcet's disease
Region	Japan

Condition
Condition	Behcet disease
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	In this study, we will first attempt to classify BD patients attending participating facilities and suspected cases that may develop BD in the future into subgroups based on relatively simple clinical information including clinical symptoms, age of onset, gender, and HLA. In addition, we will analyze the same cases over time to determine if there is any transfer between groups. In addition, a prospective study of new cases will be conducted. Next, we will analyze the relationship between each subgroup and known BD susceptibility genes, and perform GWAS restricted to each subgroup to elucidate the genetic predisposition that contributes to the pathogenesis of each subgroup and promote personalized medicine for each subtype. We will also compare cytokine profiles of serum and spinal fluid, and microbiomes of saliva and feces to investigate biological differences between subgroups, and in particular, to prove that intestinal BD is an independent pathology and prognosis. We will also accumulate basic data necessary for the establishment of a nationwide patient registry.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	None
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	Behcet's disease and suspected Behcet's disease cases
Key exclusion criteria	None
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Yohei Middle name Last name Kirino
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Stem Cell and Immune Regulation
Zip code	2360004
Address	3-9 Fukuura, Kanazawa-Ku, Yokohama, Japan
TEL	045-787-2800
Email	kirino@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Yohei Middle name Last name Kirino
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Stem Cell and Immune Regulation
Zip code	2360004
Address	3-9 Fukuura, Kanazawa-Ku, Yokohama, Japan
TEL	045-787-2800
Homepage URL
Email	kirino@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	JSPS
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	Yokohama City University Hospital
Address	3-9 Fukuura, Kanazawa-Ku, Yokohama, Japan
Tel	045-787-2800
Email	rinri@yokohama-cu.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	2022 Year 06 Month 17 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 11 Day
Date of IRB	2020 Year 08 Month 28 Day
Anticipated trial start date	2017 Year 12 Month 11 Day
Last follow-up date	2022 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Basic information such as age, sex, age of onset, duration of disease, medical history and complications, family history, and preference history will be obtained from medical records of BD patients attending participating facilities, as well as suspected cases that may develop BD in the future. Statistical analysis of these associations will be performed to attempt to classify patients into subgroups. In addition, a longitudinal analysis will be conducted from the time of onset of symptoms to determine if there is any transition between groups due to the course of the disease or treatment. In addition, we will analyze the treatment content and response to the treatment. In addition, we will analyze the association between each subgroup and disease susceptibility genes in cases in which SNPs in disease susceptibility genes have been identified. For cases that have not yet been analyzed, DNA will be extracted from blood samples collected from patients, and analysis including genome-wide association analysis will be conducted jointly by the Department of Ophthalmology and the Department of Ophthalmology of this hospital. Clinical specimens such as blood, spinal fluid, saliva, and stool will also be stored and analyzed (cytokine profile, microbiome, etc.) for comparison between subgroups. For the analysis of cytokine profiles, etc., healthy sera stored in the biobank room will be used for healthy subjects.

Management information
Registered date	2022 Year 06 Month 17 Day
Last modified on	2022 Year 06 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054809