UMIN-CTR Clinical Trial

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

Condition
Condition	Pulmonary nontuberculous mycobacterial disease and non-cystic fibrosis bronchiectasis
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the factors associated with occurrence and prognosis of the patients with pulmonary nontuberculous mycobacterial cases and non-cystic fibrosis bronchiectasis in Keio university.
Basic objectives2	Others
Basic objectives -Others	To investigate the factors associated with occurrence and prognosis of the patients with pulmonary nontuberculous mycobacterial cases and non-cystic fibrosis bronchiectasis in Keio university.
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 pulmonary nontuberculous mycobacterial diseases and non-cystic fibrosis bronchiectasis. Prognosis included death, exacerbation, and the changes of health-related quality of life and images.
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 pulmonary nontuberculous mycobacterial disease(PNTMD) or bronchiectasis with informed consent. PNTMD was diagnosed according to ATS/IDSA 2007 guideline (AJRCCM. 2007 Feb 15;175(4):367-416.). Patients with bronchicectasis was included according to EMBARC registory (ERJ Open Res. 2016 Jan 20;2(1). pii: 00081-2015.) and BRR (Chest. 2017 May;151(5):982-992.).
Key exclusion criteria	Patients who don't agree with this study. As for the diagnosis with bronchiectasis: Asymptomatic patients; Traction bronchiectasis due to interstitial lung disease; History of lung or heart trasplantation.
Target sample size	2700

Research contact person
Name of lead principal investigator	Naoki Hasegawa
Organization	Keio University Hospital
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 Hospital
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 Hospital
Institute
Department

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

Other related organizations
Co-sponsor	National institute of infectious disease
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）、結核予防会複十字病院（東京都）、国立病院機構東京医療センター（東京都）、国立病院機構松江医療センター（島根県）、福岡大学病院（福岡）、神戸市立医療センター中央市民病院（神戸）、国立病院機構刀根山病院（大阪）、国立病院機構東名古屋病院（名古屋）、永寿総合病院（東京都）、さいたま市立病院（埼玉県）、国立国際医療研究センター病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 01 Month 16 Day
Anticipated trial start date	2012 Year 05 Month 01 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	Prospective study

Management information
Registered date	2012 Year 03 Month 21 Day
Last modified on	2019 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008913