UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015881
Receipt number R000018483
Scientific Title Comprehensive analysis of the genetic factors and biomarkers involved in the pathogenesis of familial Mediterranean fever
Date of disclosure of the study information 2014/12/15
Last modified on 2019/03/15 10:38:56

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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

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

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 or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018483


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name