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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007964
Receipt No. R000009375
Scientific Title Research study for severity index of pulmonary non-tuberculous mycobacterial infection
Date of disclosure of the study information 2012/05/16
Last modified on 2019/11/19

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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 Open public recruiting
Date of protocol fixation
2011 Year 12 Month 28 Day
Date of IRB
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
2019 Year 11 Month 19 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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