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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019887
Receipt No. R000022797
Scientific Title Prospective study of the prognostic factors and clinical course in patients with Mycobacterium avium complex lung disease.
Date of disclosure of the study information 2015/11/21
Last modified on 2015/12/04

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Basic information
Public title Prospective study of the prognostic factors and clinical course in patients with Mycobacterium avium complex lung disease.
Acronym Prospective study of the prognostic factors in patients with MAC lung disease
Scientific Title Prospective study of the prognostic factors and clinical course in patients with Mycobacterium avium complex lung disease.
Scientific Title:Acronym Prospective study of the prognostic factors in patients with MAC lung disease
Region
Japan

Condition
Condition Mycobacterium avium complex (MAC) lung disease
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the prognostic factors and the factors which affect clinical course in patients with MAC lung disease
Basic objectives2 Others
Basic objectives -Others To clarify what kind of factors: patient's characteristics, laboratory examinations, sputum test, and chest X-ray or CT findings; affect prognosis and clinical course in patients with MAC lung disease. To investigate the efficacy of treatment timing, regimen and duration to prognosis and clinical course.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Poor prognostic factors in patients with MAC lung disease
Key secondary outcomes 1)procalcitonin (PCT) value in patients with MAC lung disease
2)PCT value according to the patient's severity with MAC lung disease
3)Usefulness of the serodiagnosis of MAC lung disease and the scoring system of chest images (NICE scoring system) for assess the severity of MAC lung disease, and usefulness of serial examinations.
4)The effect of treatment timing, regimen and duration to prognosis and clinical course

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 aged 20 years old or over.
fulfilled the criteria of MAC lung disease in 2007 ATS/IDSA criteria.
within 12 months after diagnosis and untreated.
Key exclusion criteria thirteen months or more after diagnosis or treated already.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Ishida
Organization Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL 086-422-0210
Email ishidat@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Ito
Organization Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL 086-422-0210
Homepage URL
Email ai12306@kchnet.or.jp

Sponsor
Institute Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Institute
Department

Funding Source
Organization Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Organization
Division
Category of Funding Organization Self funding
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 公益財団法人大原記念倉敷中央医療機構倉敷中央病院(岡山県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 21 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
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 21 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is prospective observational cohort study.
Subjects: All patients diagnosed with MAC lung disease between 21 November 2015 to 31 December 2025 in Kurashiki Central Hospital.
Examination items: Vital signs, blood examinations, sputum examinations, chest X-ray photo and chest computed tomography

Management information
Registered date
2015 Year 11 Month 21 Day
Last modified on
2015 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022797

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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