UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study for nontuberculous mycobacterial lung disease and non-cystic fibrosis bronchiectasis
Title of the study (Brief title)	Observational study for nontuberculous mycobacterial lung disease and non-cystic fibrosis bronchiectasis
Region	Japan

Condition
Condition	Nontuberculous mycobacterial lung disease and non-cystic fibrosis bronchiectasis
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the factors associated with occurrence and prognosis of the patients with nontuberculous mycobacterial lung disease and non-cystic fibrosis bronchiectasis.
Basic objectives2	Others
Basic objectives -Others	To investigate the factors associated with occurrence and prognosis of the patients with nontuberculous mycobacterial lung disease and non-cystic fibrosis bronchiectasis.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The factors associated with occurrence and prognosis of patients with nontuberculous mycobacterial lung disease and non-cystic fibrosis bronchiectasis.
Key secondary outcomes	Nothing

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 diagnosed or suspected with nontuberculous mycobacterial lung disease and non-cystic fibrosis bronchiectasis.If patients had already died, they are eligible regardless of informed consent.
Key exclusion criteria	Patients who don't agree with this study.
Target sample size	1000

Research contact person
Name of lead principal investigator	Naoki Hasegawa
Organization	Keio University School of Medicine
Division name	Center for Infectious Diseases and Infection Control
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
TEL	03-3353-3710
Email	n-hasegawa@z8.keio.jp

Public contact
Name of contact person	Takanori Asakura
Organization	Keio University School of Medicine
Division name	Division of Pulmonary Medicine, Department of Medicine
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
TEL	03-3353-1211
Homepage URL
Email	takanori.asakura@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	慶應義塾大学病院（東京都）、複十字病院（東京都）、国立国際医療研究センター病院（東京都）、東名古屋病院（愛知県）、永寿総合病院（東京都）、国立病院機構東京医療センター（東京都）国立感染症研究所（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 02 Month 17 Day
Anticipated trial start date	2017 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Multiceter prospective observational study

Management information
Registered date	2017 Year 03 Month 09 Day
Last modified on	2017 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030425