UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019887 |
|---|---|
| Receipt number | 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 18:27:02 |
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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
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
ai12306@kchnet.or.jp
Sponsor or person
Institute
Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022797
