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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020887
Receipt No. 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 2017/04/05

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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
Middle name
Last name Kazuyuki Nakagome
Organization Saitama Medical University
Division name Department of Respiratory Medicine
Zip code
Address 38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1319
Email nakagomek-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Nakagome
Organization Saitama Medical University
Division name Department of Respiratory Medicine
Zip code
Address 38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1319
Homepage URL
Email nakagomek-tky@umin.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
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 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
2017 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024095

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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