UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007964 |
|---|---|
| Receipt number | 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 | 2020/11/20 23:45:36 |
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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
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）
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
Value
https://center6.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 |
