UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive analysis of the genetic factors and biomarkers involved in the pathogenesis of familial Mediterranean fever
Acronym	Genetic and serological analysis in familial Mediterranean fever
Scientific Title	Comprehensive analysis of the genetic factors and biomarkers involved in the pathogenesis of familial Mediterranean fever
Scientific Title:Acronym	Genetic and serological analysis in familial Mediterranean fever
Region	Japan

Condition
Condition	Familial Mediterranean fever
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	o determine new biomarkers and genes related to the pathogenesis of FMF, and to establish genetic diagnosis of the real FMF
Basic objectives2	Others
Basic objectives -Others	Hypothesis exploratory study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To identify novel genes that improve the diagnosis of FMF
Key secondary outcomes	To determine new biomarkers that assist the disease activity of FMF

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	-Familial Mediterranean fever patients meet the diagnostic criteria (FMF) and FMF and difficult cases clinical differential(Adult-onset Still's disease, etc.) -Patients can consent obtained in documents from the person and Daidaku person.
Key exclusion criteria	-Patients who do not correspond to the selection criteria
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Astushi Kawakami
Organization	Nagasaki University Hospital
Division name	First department of internal medicine
Zip code
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7260
Email	atsushik@nagasaki-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Tomohiro oga
Organization	Nagasaki University Hospital
Division name	First department of internal medicine
Zip code
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7874
Homepage URL
Email	tkoga@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research (KAKENHI)ect
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2014 Year 12 Month 15 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	Completed
Date of protocol fixation	2014 Year 10 Month 08 Day
Date of IRB	2014 Year 09 Month 30 Day
Anticipated trial start date	2014 Year 10 Month 08 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Hypothesis exploratory study

Management information
Registered date	2014 Year 12 Month 09 Day
Last modified on	2019 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018483