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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030211
Receipt No. R000034480
Scientific Title Evaluation of antigenicity of pigeon immunoglobulin lambda-like polypeptide-1 for the diagnosis of bird-related hypersensitivity pneumonitis.
Date of disclosure of the study information 2017/12/07
Last modified on 2017/12/01

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Basic information
Public title Evaluation of antigenicity of pigeon immunoglobulin lambda-like polypeptide-1 for the diagnosis of bird-related hypersensitivity pneumonitis.
Acronym Evaluation of antigenicity of pigeon IGLL-1 for the diagnosis of bird-related hypersensitivity pneumonitis.
Scientific Title Evaluation of antigenicity of pigeon immunoglobulin lambda-like polypeptide-1 for the diagnosis of bird-related hypersensitivity pneumonitis.
Scientific Title:Acronym Evaluation of antigenicity of pigeon IGLL-1 for the diagnosis of bird-related hypersensitivity pneumonitis.
Region
Japan

Condition
Condition Hypersensitivity pneumonitis
Classification by specialty
Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purposes of this study were to evaluate the antigenicity of pigeon immunoglobulin lambda-like polypeptide-1 for patients with bird-related hypersensitivity pneumonitis by immunological assays; detecting specific antibodies against pigeon IGLL-1 by ELISA, measuring lymphocyte proliferation responses to pigeon IGLL-1 by FACS analysis and 3H thymidine incorporation assay, and to analyze the distribution and amount of pigeon IGLL-1 in environment at patients home whether it can be used as a predictive marker.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Find the significant difference by immunological assays between disease and control group.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Collect the 20ml venous blood for immunological assays.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Criteria for selecting participants: Adult staff member who are walking at Department of Respiratory Medicine, Tokyo Medical and Dental University.
Key exclusion criteria Exclude patients who meet the following criteria:
1)under age 20.
2)Judge as an inappropriate patient by principal investigators.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Shirai
Organization Tokyo Medical and Dental University
Division name Department of Respiratory Medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5954
Email tshipulm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Shirai
Organization Tokyo Medical and Dental University
Division name Department of Respiratory Medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5954
Homepage URL
Email tshipulm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 07 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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 01 Day
Last modified on
2017 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034480

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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