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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027002
Receipt No. 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

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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
Institute Kobe University
Institute
Department

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
URL(English) https://upload.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


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