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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005247
Receipt No. R000006239
Scientific Title Analysis of geographical distribution, factors associated with occurence and prognosis among patients with pulmonary nontuberculous mycobacterial infection in Nagasaki, Japan
Date of disclosure of the study information 2011/03/15
Last modified on 2014/03/24

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Basic information
Public title Analysis of geographical distribution, factors associated with occurence and prognosis among patients with pulmonary nontuberculous mycobacterial infection in Nagasaki, Japan
Acronym Clinical analysis of pulmonary nontuberculous mycobacterial diseases in Nagasaki, Japan
Scientific Title Analysis of geographical distribution, factors associated with occurence and prognosis among patients with pulmonary nontuberculous mycobacterial infection in Nagasaki, Japan
Scientific Title:Acronym Clinical analysis of pulmonary nontuberculous mycobacterial diseases in Nagasaki, Japan
Region
Japan

Condition
Condition pulmonary nontuberculous mycobacterial diseases
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate geographical distribution of nontuberulous mycobacterium species, factors associated with occurence and prognosis of the patients with pulmonary nontuberculous mycobacterial cases in Nagasaki, Japan.
Basic objectives2 Others
Basic objectives -Others To investigate geographical distribution of nontuberulous mycobacterium species, factors associated with occurence and prognosis of the patients with pulmonary nontuberculous mycobacterial cases in Nagasaki, Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes distribution of nontuberculous mycobacterium species, factors associated with occurence and prognosis in patinets with pulmonary nontuberculous mycobacterial diseases.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed as nontuberculous mycobacterial diseases in Nagasaki University Hospital and ralated facilities between 2001 and 2010.
Diagnostic criteria was matched with Japanese guidelines for the diagnosis of pulmonary nontuberculous mycobacterium diseases established by Tuberculosis and the Japanese Respiratory Society in 2008.
Key exclusion criteria None.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kohno
Organization Nagasaki University Hospital
Division name Director
Zip code
Address 1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL 095-819-7273
Email yamamoto-ngs@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Yamamoto
Organization Nagasaki University Hospital
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL 095-819-7273
Homepage URL
Email yamamoto-ngs@umin.ac.jp

Sponsor
Institute Nagasaki evaluation organization for clinical interventions
Institute
Department

Funding Source
Organization Nagasaki evaluation organization for clinical interventions
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
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

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2013 Year 04 Month 30 Day
Date of closure to data entry
2013 Year 12 Month 28 Day
Date trial data considered complete
2013 Year 12 Month 28 Day
Date analysis concluded
2014 Year 01 Month 16 Day

Other
Other related information retrospective study

Management information
Registered date
2011 Year 03 Month 14 Day
Last modified on
2014 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006239

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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