UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007546 |
|---|---|
| Receipt number | R000008913 |
| Scientific Title | Observational study for pulmonary nontuberculous mycobacterial infection and non-cystic fibrosis bronchiectasis. |
| Date of disclosure of the study information | 2012/03/23 |
| Last modified on | 2019/02/09 15:44:03 |
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Basic information
Public title
Observational study for pulmonary nontuberculous mycobacterial infection and non-cystic fibrosis bronchiectasis.
Acronym
Observational study for pulmonary nontuberculous mycobacterial infection and non-cystic fibrosis bronchiectasis.
Scientific Title
Observational study for pulmonary nontuberculous mycobacterial infection and non-cystic fibrosis bronchiectasis.
Scientific Title:Acronym
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
| 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
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
takanori.asakura@gmail.com
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
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
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 |
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
| 2012 | Year | 01 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008913
