UMIN-CTR Clinical Trial

Basic information
Public title	Research study for severity index of pulmonary non-tuberculous mycobacterial infection
Acronym	QOL and severity of patients with pulmonary non-tuberculous mycobacterial infection
Scientific Title	Research study for severity index of pulmonary non-tuberculous mycobacterial infection
Scientific Title:Acronym	QOL and severity of patients with pulmonary non-tuberculous mycobacterial infection
Region	Japan

Condition
Condition	Pulmonary non-tuberculous mycobacterial disease
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the factors associated with severity of the patients with pulmonary non-tuberculous mycobacterial cases in Keio university.
Basic objectives2	Others
Basic objectives -Others	Taking clinical examinations like QOL score, serological exam, radiological imaging for investigation of the factors associated with severity of the patients with pulmonary non-tuberculous mycobacterial cases in Keio university,
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The factors associated with severity of patients with pulmonary non-tuberculous mycobacterial diseases.
Key secondary outcomes	none

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 visit our hospital who diagnosed lung non-tuberculous mycobacterium infection with informed consent.
Key exclusion criteria	patients who don't agree with this study.
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Hasegawa
Organization	Keio University Hospital
Division name	Center for Infectious Diseases and Infection Control,
Zip code
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	1st name Middle name Last name Takanori Asakura
Organization	Keio University Hospital
Division name	Division of Pulmonary Medicine, Department of Medicine
Zip code
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)

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	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）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 16 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	No longer recruiting
Date of protocol fixation	2011 Year 12 Month 28 Day
Date of IRB	2011 Year 12 Month 26 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	chest plain CT, DLco, serological test(CBC, biochemical exam, BNP, KL-6, SP-D, anti GPL core IgA antibody, QFT, 1-3 beta-D glucan, Aspergillus antigen, Apergillosis precipitin antibody), health-related quality of life.

Management information
Registered date	2012 Year 05 Month 15 Day
Last modified on	2020 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009375