UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020887 |
|---|---|
| Receipt number | R000024095 |
| Scientific Title | Investigation of eosinophil activating factor in bronchoalveolar lavage fluid of acute eosinophilic pneumonia |
| Date of disclosure of the study information | 2016/04/02 |
| Last modified on | 2022/02/10 14:43:39 |
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Basic information
Public title
Investigation of eosinophil activating factor in bronchoalveolar lavage fluid of acute eosinophilic pneumonia
Acronym
Investigation of eosinophil activating factor in bronchoalveolar lavage fluid of acute eosinophilic pneumonia
Scientific Title
Investigation of eosinophil activating factor in bronchoalveolar lavage fluid of acute eosinophilic pneumonia
Scientific Title:Acronym
Investigation of eosinophil activating factor in bronchoalveolar lavage fluid of acute eosinophilic pneumonia
Region
| Japan |
Condition
Condition
Acute eosinophilic pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of eosinophil activating factor in bronchoalveolar lavage fluid of acute eosinophilic pneumonia
Basic objectives2
Others
Basic objectives -Others
We examine the expression of an already-known eosinophil activating factor or involvement of other immune cells in serum, bronchoalveolar lavage fluid or lung tissue of acute eosinophilic pneumonia, chronic eosinophilic pneumonia or sarcoidosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Expression of periostin in serum, bronchoalveolar lavage fluid or lung tissue
Key secondary outcomes
Percentage of innate lymphoid cells in bronchoalveolar lavage fluid
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with acute eosinophilic pneumonia, patients with chronic eosinophilic pneumonia and patients with sarcoidosis
Key exclusion criteria
Patients who have been treated by systemic corticosteroid
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Nakagome |
Organization
Saitama Medical University
Division name
Department of Respiratory Medicine
Zip code
350-0495
Address
38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1319
nakagome@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Nakagome |
Organization
Saitama Medical University
Division name
Department of Respiratory Medicine
Zip code
350-0495
Address
38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1319
Homepage URL
nakagome@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1125
hirb@saitama-med.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
埼玉医科大学呼吸器内科、順天堂大学呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examine the expression of an already-known eosinophil activating factor or involvement of other immune cells in serum, bronchoalveolar lavage fluid or lung tissue of acute eosinophilic pneumonia, chronic eosinophilic pneumonia or sarcoidosis
Management information
Registered date
| 2016 | Year | 02 | Month | 04 | Day |
Last modified on
| 2022 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024095
| 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 |
