UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021692 |
|---|---|
| Receipt number | R000025025 |
| Scientific Title | Genetic Analysis of Japanese Pulmonary Non-Tuberculous Mycobacteria(NTM)(Multicenter-trial) |
| Date of disclosure of the study information | 2016/03/30 |
| Last modified on | 2019/01/07 13:39:28 |
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Basic information
Public title
Genetic Analysis of Japanese Pulmonary Non-Tuberculous Mycobacteria(NTM)(Multicenter-trial)
Acronym
Genetic Analysis of Japanese Pulmonary Non-Tuberculous Mycobacteria(NTM-GWAS project)
Scientific Title
Genetic Analysis of Japanese Pulmonary Non-Tuberculous Mycobacteria(NTM)(Multicenter-trial)
Scientific Title:Acronym
Genetic Analysis of Japanese Pulmonary Non-Tuberculous Mycobacteria(NTM-GWAS project)
Region
| Japan |
Condition
Condition
Pulmonary NTM , Healthy volunteer
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore disease susceptibility genes of pulmonary NTM and bronchiectasis
Basic objectives2
Others
Basic objectives -Others
To analyze function of susceptible genes by using patients^derived samples(PBMCs) and ,human and murine cell lines.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significantly observed SNPs among pulmonary NTM patients
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
pulmonary NTM patients and their family members whose genetic analysis can obtain with written consent
Key exclusion criteria
patients who investigators judge inappropriate
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Hoshino |
Organization
National Institute of Infectious Diseases, Leprosy Research Center
Division name
Department of Mycobacteriology
Zip code
Address
4-2-1 Aoba-cho Higashimurayama Tokyo Japan
TEL
042-202-6061
yhoshino@niid.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ho Namkoong |
Organization
Keio University School of Medicine
Division name
Department of Medicine Division of Pulmonary Medicine
Zip code
Address
35 Shinanomachi Shinjyuku Tokyo
TEL
03-3353-1211
Homepage URL
hounamugun@gmail.com
Sponsor or person
Institute
NTM-JRC
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 03 | Month | 30 | 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 | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design:Case-control study
Patient Recruitment method:Pulmonary NTM patients diagnosed accordance with 2007 ATS/IDSA statements
Meaured data:SNP array
Management information
Registered date
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025025
