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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name