UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of utility of antigen-specific IgG antibodies of hypersensitivity pneumonitis.
Acronym	Evaluation of utility of antigen-specific IgG antibodies of hypersensitivity pneumonitis.
Scientific Title	Evaluation of utility of antigen-specific IgG antibodies of hypersensitivity pneumonitis.
Scientific Title:Acronym	Evaluation of utility of antigen-specific IgG antibodies of 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 detect of antigen-specific IgG antibodies of fungi or bacteria-induced hypersensitivity pneumonitis by ImmunoCAP assays, and evaluate the utility of antibodies by comparing with hypersensitivity pneumonitis by the other antigens or healthy controls.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Find the significant difference of the amount of antigen-specific IgG antibodies in serum between disease and control group by ImmunoCAP assays.
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	30

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Shirai
Organization	Tokyo Medical and Dental University
Division name	Department of Respiratory Medicine
Zip code	113-8510
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 Tsuyoshi Middle name Last name Shirai
Organization	Tokyo Medical and Dental University
Division name	Department of Respiratory Medicine
Zip code	113-8510
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	IRB of Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel	0338136111
Email	syomu1.adm@tmd.ac.jp

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	2021 Year 09 Month 27 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	2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 12 Month 01 Day
Last follow-up date	2026 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 27 Day
Last modified on	2022 Year 09 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052042