UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048089
Receipt No. R000054809
Scientific Title Establishment of a national registry for Behcet's disease
Date of disclosure of the study information 2022/06/17
Last modified on 2022/06/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.