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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012029
Receipt No. R000014060
Scientific Title Prospective cohort study of Nontuberculous mycobacteriosis, especially M. intracelluare.
Date of disclosure of the study information 2013/10/15
Last modified on 2019/10/12

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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
2021 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
2019 Year 10 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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