UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044077 |
|---|---|
| Receipt number | R000050325 |
| Scientific Title | Combination of Tryptase and IL-33 in Bronchoalveolar Lavage Fluid May Predict the Types of Eosinophilic Pneumonia and Disease Recurrence |
| Date of disclosure of the study information | 2021/04/29 |
| Last modified on | 2021/04/29 22:31:31 |
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Basic information
Public title
Combination of Tryptase and IL-33 in Bronchoalveolar Lavage Fluid May Predict the Types of Eosinophilic Pneumonia and Disease Recurrence
Acronym
Tryptase and IL-33 in BALF of EP patients
Scientific Title
Combination of Tryptase and IL-33 in Bronchoalveolar Lavage Fluid May Predict the Types of Eosinophilic Pneumonia and Disease Recurrence
Scientific Title:Acronym
Tryptase and IL-33 in BALF of EP patients
Region
| Japan |
Condition
Condition
Patients diagnosed with eosinophilic pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the differences in tryptase and Interleukin-33 (IL-33) levels in bronchoalveolar lavage fluid (BALF) among several types of EP. We also evaluated the differences in these biomarkers between the recurrent and non-recurrent cases.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tryptase and IL-33 in BALF
Key secondary outcomes
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
Patients who was diagnosed with eosinophilic pneumonia
Key exclusion criteria
history of malignancy, idiopathic eosinophilia
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Akaba |
Organization
Tokyo Women's Medical University
Division name
Department of respiratory medicine
Zip code
162-0054
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
81-3-3353-8111
akaba.tomohiro@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Akaba |
Organization
Tokyo Women's Medical University
Division name
Department of respiratory medicine
Zip code
162-0054
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
81-3-3353-8111
Homepage URL
akaba.tomohiro@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University IRB
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel
81-3-3353-8111
rinri.bm@twmu.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 | 04 | Month | 29 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Publication of results
Partially published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Number of participants that the trial has enrolled
35
Results
We enrolled 15 patients with chronic EP (CEP), 5 with acute EP (AEP), 10 with drug-induced EP, and 6 with angiitis-related EP.
Results date posted
| 2021 | Year | 04 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients diagnosed with eosinophilic pneumonia were enrolled.
Participant flow
Patients diagnosed with eosinophilic pneumonia were enrolled.
Adverse events
N/A
Outcome measures
We enrolled 15 patients with chronic EP (CEP), 5 with acute EP (AEP), 10 with drug-induced EP, and 6 with angiitis-related EP.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2006 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We prospectively collected the clinical data of patients with EP diagnosed between 2006 and 2015 in our institution. Bronchoscopy was performed before steroid treatment, and BALF was collected. The clinical characteristics of EP patients and tryptase and IL-33 levels in BALF were evaluated.
Management information
Registered date
| 2021 | Year | 04 | Month | 29 | Day |
Last modified on
| 2021 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050325
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
