UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Genetic Analysis of Japanese Pulmonary Non-Tuberculous Mycobacteria(NTM)(Multicenter-trial)
Title of the study (Brief title)	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	Yoshihiko Hoshino
Organization	National Institute of Infectious Diseases, Leprosy Research Center
Division name	Department of Mycobacteriology
Address	4-2-1 Aoba-cho Higashimurayama Tokyo Japan
TEL	042-202-6061
Email	yhoshino@niid.go.jp

Public contact
Name of contact person	Ho Namkoong
Organization	Keio University School of Medicine
Division name	Department of Medicine Division of Pulmonary Medicine
Address	35 Shinanomachi Shinjyuku Tokyo
TEL	03-3353-1211
Homepage URL
Email	hounamugun@gmail.com

Sponsor
Institute	NTM-JRC
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 12 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025025