UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study of Nontuberculous mycobacteriosis, especially M. intracelluare.
Acronym	NTM registry
Scientific Title	Prospective cohort study of Nontuberculous mycobacteriosis, especially M. intracelluare.
Scientific Title:Acronym	NTM registry
Region	Japan

Condition
Condition	Nontuberculous mycobacteriosis
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Surveillance of NTM, especially M. intracellulare.
Basic objectives2	Others
Basic objectives -Others	Surveillance of incidence, exacerbation, strain
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Surveillance of incidence, exacerbation, strain
Key secondary outcomes	Imaging, strain factor, QOL

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	1. Informed consent is obtained 2. Patient who was diagnosed of NTM, examined with Chest X-ray or Chest CT, and demonstrated M. intracelluare, 3. No history of treatment for M. intracelluare
Key exclusion criteria	1.Patient who is judged as an inappropriate case by the doctor in charge 2.Patient demonstrated other than M. intracellulare
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Masaki Fujita
Organization	Fukuoka University
Division name	Department of Respiratory Medicine
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonanku, Fukuoka
TEL	092-801-1011
Email	mfujita@fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Fujita
Organization	Fukuoka University
Division name	Department of Respiratory Medicine
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonanku, Fukuoka
TEL	092-801-1011
Homepage URL
Email	mfujita@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Hospital
Institute
Department

Funding Source
Organization	Fukuoka University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Fukuoka Mycobacteriosis Conference
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Fukuoka University Hospital
Address	7-45-1 Nanakuma Jonanku, Fukoka
Tel	092-801-1011
Email	rinshou@adm.fukuoka-u.ac.jp

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	九州大学病院呼吸器科（福岡県） 九州中央病院・呼吸器内科（福岡県） 済生会飯塚嘉穂病院・呼吸器内科（福岡県） 国立病院機構大牟田病院・呼吸器科（福岡県） 国立病院機構福岡病院・呼吸器科（福岡県） 国立病院機構福岡東医療センター・呼吸器科（福岡県） 西福岡病院・呼吸器内科（福岡県） 直方中央病院・呼吸器内科（福岡県） 浜の町病院・呼吸器科（福岡県） 原三信病院・呼吸器内科（福岡県） 福岡赤十字病院・呼吸器内科（福岡県） 福岡結核予防センター・呼吸器内科（福岡県） 福西会病院・呼吸器内科（福岡県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 15 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	2013 Year 10 Month 12 Day
Date of IRB	2013 Year 11 Month 20 Day
Anticipated trial start date	2013 Year 10 Month 16 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Ongoing

Management information
Registered date	2013 Year 10 Month 14 Day
Last modified on	2021 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014060