UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017334
Receipt number R000020112
Scientific Title The organization accumulation of the inflammatory cell and the influence that the environmental allergen (cedar, dermatophagoides) to function expression
Date of disclosure of the study information 2015/06/01
Last modified on 2018/10/31 12:40:57

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Basic information

Public title

The organization accumulation of the inflammatory cell and the influence that the environmental allergen (cedar, dermatophagoides) to function expression

Acronym

Influence to the inflammatory cell with the environmental allergen

Scientific Title

The organization accumulation of the inflammatory cell and the influence that the environmental allergen (cedar, dermatophagoides) to function expression

Scientific Title:Acronym

Influence to the inflammatory cell with the environmental allergen

Region

Japan


Condition

Condition

allergy disease

Classification by specialty

Pneumology Clinical immunology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Influence on inflammatory cell.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Cell activation confirmation

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

20 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

The person who agreed to the purpose of the examination

Key exclusion criteria

Malignant tumor, pregnant woman

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takehito KOBAYASHI

Organization

Saitama Medical University Hospital

Division name

Department of General Internal Medicine

Zip code


Address

Morohongo 38 Moroyama-machi Irumagun, Saitama

TEL

049-276-1667

Email

kobatake@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takehito KOBAYASHI

Organization

Saitama Medical University Hospital

Division name

Department of General Internal Medicine

Zip code


Address

Morohongo 38 Moroyama-machi Irumagun, Saitama

TEL

049-276-1667

Homepage URL


Email

kobatake@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University Hospital
MEXT KAKENHI(26860758)

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

埼玉医科大学


Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 01 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

2015 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

basic research


Management information

Registered date

2015 Year 04 Month 30 Day

Last modified on

2018 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020112


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name