UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027002
Receipt number R000029570
Scientific Title Identification of lettuce allergen and investigation of atopic and asthmatic diathesis related to lettuce-induced asthma.
Date of disclosure of the study information 2017/04/17
Last modified on 2017/04/15 16:15:13

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Basic information

Public title

Identification of lettuce allergen and investigation of atopic and asthmatic diathesis related to lettuce-induced asthma.

Acronym

Identification of lettuce allergen and investigation of atopic and asthmatic diathesis related to lettuce-induced asthma.

Scientific Title

Identification of lettuce allergen and investigation of atopic and asthmatic diathesis related to lettuce-induced asthma.

Scientific Title:Acronym

Identification of lettuce allergen and investigation of atopic and asthmatic diathesis related to lettuce-induced asthma.

Region

Japan


Condition

Condition

asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify casual protein of lettuce induced asthma.

Basic objectives2

Others

Basic objectives -Others

To estimate the symptom of lettuce induced asthma.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of casual protein of lettuce induced asthma.

Key secondary outcomes

Atopic diathesis of lettuce-induced asthma patients. skin prick test, blood test, lettuce-specific inhalation test, peak flow.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who have respiratory symdrome related to lettuce at Awaji prefectual hospital

Key exclusion criteria

none

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Kamiryo

Organization

Kobe University Hospital

Division name

Division of Respiratory Medicine

Zip code


Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

+81-78-382-5660

Email

hiroshio@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Nagano

Organization

Kobe University Graduate School of Medicine

Division name

Division of Respiratory Medicine, Department of Internal Medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

+81-78-382-5660

Homepage URL


Email

tnagano@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

兵庫県立淡路医療センター/Hyogo Prefectural Awaji Medical center


Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 17 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

Enrolling by invitation

Date of protocol fixation

2016 Year 11 Month 21 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Skin prick test,blood test, and Lettuce-specific inhalation test will be performed.


Management information

Registered date

2017 Year 04 Month 15 Day

Last modified on

2017 Year 04 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029570


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name