UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008456
Receipt number R000009941
Scientific Title Functional linkage between the genetic polymorphisms of innate immunity regulatory genes and diseases in Japanese subjects.
Date of disclosure of the study information 2012/07/19
Last modified on 2012/07/19 19:21:09

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Basic information

Public title

Functional linkage between the genetic polymorphisms of innate immunity regulatory genes and diseases in Japanese subjects.

Acronym

Genetic polymorphisms of innate immunity regulatory genes

Scientific Title

Functional linkage between the genetic polymorphisms of innate immunity regulatory genes and diseases in Japanese subjects.

Scientific Title:Acronym

Genetic polymorphisms of innate immunity regulatory genes

Region

Japan


Condition

Condition

heart disease,connective tissue disease, uveitis, Adult T cell Leukemia, human T-cell leukemia virus type 1-carriers, healthy subject

Classification by specialty

Cardiology Hematology and clinical oncology Clinical immunology
Ophthalmology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Functional linkage between the genetic polymorphisms of innate immunity regulatory genes and diseases in Japanese subjects.

Basic objectives2

Others

Basic objectives -Others

Single nucleotide polymorphism analysis of innate immunity regulatory genes

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Single nucleotide polymorphism

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)heart disease,connective tissue disease, uveitis, Adult T cell Leukemia, human T-cell leukemia virus type 1-carriers, healthy subject
2)Patients who provided written informed consents to participate the study prior to enrollment

Key exclusion criteria

Other conditions considered inappropriate by attending physician

Target sample size

520


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Nishizono

Organization

Oita University Faculty of Medicine

Division name

Department of Microbiology

Zip code


Address

1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan

TEL

097-586-5712

Email



Public contact

Name of contact person

1st name
Middle name
Last name Satoko Nakano

Organization

Oita University Faculty of Medicine

Division name

Department of Microbiology

Zip code


Address

1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan

TEL

097-586-5712

Homepage URL


Email

oita_microbio-admin@umin.ac.jp


Sponsor or person

Institute

Department of Microbiology, Oita University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

大分大学医学部附属病院(大分県)


Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 19 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

Open public recruiting

Date of protocol fixation

2012 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Single nucleotide polymorphism


Management information

Registered date

2012 Year 07 Month 17 Day

Last modified on

2012 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009941


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name