UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of lymphoid cells in bronchoalveolar lavage fluid of interstitial pneumonia
Acronym	Investigation of lymphoid cells in bronchoalveolar lavage fluid of interstitial pneumonia
Scientific Title	Investigation of lymphoid cells in bronchoalveolar lavage fluid of interstitial pneumonia
Scientific Title:Acronym	Investigation of lymphoid cells in bronchoalveolar lavage fluid of interstitial pneumonia
Region	Japan

Condition
Condition	Interstitial pneumonia
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of lymphoid cells in bronchoalveolar lavage fluid of interstitial pneumonia
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Percentage of subsets of lymphoid cells in bronchoalveolar lavage fluid of interstitial pneumonia
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 with interstitial pneumonia -Willingness and ability to give written Informed Consent
Key exclusion criteria	-Is unlikely to cooperate with the requirements of the study including having the ability to communicate with the investigator appropriately.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Norihiro Middle name Last name Harada
Organization	Juntendo University school of medicine
Division name	Department of respiratory medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5802-1063
Email	nor@juntendo.ac.jp

Public contact
Name of contact person	1st name Norihiro Middle name Last name Harada
Organization	Juntendo University school of medicine
Division name	Department of respiratory medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5802-1063
Homepage URL
Email	nor@juntendo.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
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	Juntendo University Research Ethics Committee
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-3813-3111
Email	chiken@juntendo.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	2016 Year 11 Month 17 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	Completed
Date of protocol fixation	2016 Year 05 Month 20 Day
Date of IRB	2016 Year 06 Month 17 Day
Anticipated trial start date	2016 Year 06 Month 17 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The method of recruitment; Subjects having any of the inclusion criteria will be recruited from our outpatient clinic at Juntendo University Hospital and Saitama Medical University Hospital by March 31, 2020. We examine the subsets of lymphoid cells in bronchoalveolar lavage fluid of interstitial pneumonia.

Management information
Registered date	2016 Year 11 Month 17 Day
Last modified on	2020 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028637