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
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
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
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
