UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive analysis of bronchoalveolar lavage fluid in diffuse lung diseases
Acronym	Comprehensive analysis of bronchoalveolar lavage fluid in diffuse lung diseases
Scientific Title	Comprehensive analysis of bronchoalveolar lavage fluid in diffuse lung diseases
Scientific Title:Acronym	Comprehensive analysis of bronchoalveolar lavage fluid in diffuse lung diseases
Region	Japan

Condition
Condition	Diffuse lung disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate pathology of various diffuse lung diseases
Basic objectives2	Others
Basic objectives -Others	To investigate pathology of various diffuse lung diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comprehensive analysis of various elements in bronchoalveolar lavage fluid
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	Subjects who undertook bronchoscopy due to their diffuse lung disease
Key exclusion criteria	Under 20 years old
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Shonosuke Middle name Last name Tajima
Organization	Kawasaki Medical School
Division name	Respiratory Medicine
Zip code	701-0162
Address	577 matsushima, Kurashiki city
TEL	086-462-1111
Email	shonosuke@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Shonosuke Middle name Last name Tajima
Organization	Kawasai Medical School
Division name	Respiratory Medicine
Zip code	700-0162
Address	577 matsushima, Kurashiki city
TEL	086-462-1111
Homepage URL
Email	shonosuke@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	None
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	Kawasaki Medical School ethics committee
Address	577 matsushima, Kurashiki city
Tel	086-464-1076
Email	Kmsrec@med.kawasaki-m.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	2019 Year 09 Month 09 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	95
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	No longer recruiting
Date of protocol fixation	2019 Year 10 Month 01 Day
Date of IRB	2019 Year 11 Month 11 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The subject is a person who performs bronchoscopy for diffuse lung disease over the age of 20 years. If consent is obtained, use bronchoalveolar lavage fluid and blood samples.The recrusent period is when 90 cases of the planned number of cases are gathered.

Management information
Registered date	2019 Year 09 Month 09 Day
Last modified on	2021 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043212