UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005247 |
|---|---|
| Receipt number | 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 11:49:04 |
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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
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
yamamoto-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki evaluation organization for clinical interventions
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006239
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
