UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045583 |
|---|---|
| Receipt number | R000052042 |
| Scientific Title | Evaluation of utility of antigen-specific IgG antibodies of hypersensitivity pneumonitis. |
| Date of disclosure of the study information | 2021/09/27 |
| Last modified on | 2022/09/28 20:22:36 |
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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
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
tshipulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052042
