UMIN-CTR Clinical Trial

Basic information
Public title	Study on diagnosis and treatment of Mycobacterium avium complex pulmonary disease
Acronym	Study on diagnosis and treatment of Mycobacterium avium complex pulmonary disease
Scientific Title	Prospective, observational study on diagnosis and treatment of Mycobacterium avium complex pulmonary disease in a clinical practice covered by Japanese healthcare insurance
Scientific Title:Acronym	Prospective, observational study on diagnosis and treatment of Mycobacterium avium complex pulmonary disease in a clinical practice covered by Japanese healthcare insurance
Region	Japan

Condition
Condition	Mycobacterium avium complex pulmonary disease
Classification by specialty	Medicine in general Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relationship between the effects of multidrug chemotherapy for Mycobacterium avium complex pulmonary disease and long-term prognosis, and to search for useful prognostic predictors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1)Relationship between the outcomes of multidrug chemotherapy and long-term survival prognosis 2)Search for useful prognostic predictors
Key secondary outcomes	Evaluation as prognostic factors the following: 1) clinical characteristics 2) chest radiographic findings 3) results of sputum smear-culture examinations for acid-fast bacteria, and serobar 4) results of blood examinations (especially serum antibodies against acid-fast bacteria)

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with Mycobacterium avium complex pulmonary disease met the criteria advocated by the American Thoracic Society 1997 2)Patients who can visit the hospital regularly for 5 years or more 3)Signed agreement to participate in the study
Key exclusion criteria	1)Patients known to be seropositive for human immunodeficiency virus 2)Judged inadequate to participate in the study by their physicians
Target sample size	41

Research contact person
Name of lead principal investigator	1st name Ryoji Middle name Last name Maekura
Organization	National Hospital Organization Osaka Toneyama Medical Center
Division name	Department of Respiratory Medicine
Zip code	560-8552
Address	5-1-1 Toneyama, Toyonaka, Osaka, Japan.
TEL	06-6853-2001
Email	mae.ryoji@gmail.com

Public contact
Name of contact person	1st name Ryoji Middle name Last name Maekura
Organization	Graduate School of Medical Safety Management, Jikei University of Health Care Sciences
Division name	Graduate school
Zip code	532-0003
Address	1-2-8 Miyahara, Yodogawa-ku, Osaka, Japan
TEL	06-6150-1336
Homepage URL
Email	mae.ryoji@gmail.com

Sponsor
Institute	National Hospital Organization Osaka Toneyama Medical Center
Institute
Department

Funding Source
Organization	MHLW (Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Hospital Organization Osaka Toneyama Medical Center
Address	5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
Tel	06-6853-2001
Email	410-chiken@mail.hosp.go.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	独立行政法人国立病院機構大阪刀根山医療センター(大阪府）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 22 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	94
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	Completed
Date of protocol fixation	2004 Year 05 Month 10 Day
Date of IRB	2004 Year 05 Month 21 Day
Anticipated trial start date	2004 Year 05 Month 21 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1)Relationship between the outcomes of multidrug chemotherapy and long-term survival prognosis 2)Search for useful prognostic predictors Evaluation as prognostic factors the following: 1) clinical characteristics 2) chest radiographic findings 3) results of sputum smear-culture examinations for acid-fast bacteria 4) results of blood examinations (especially serum antibodies against acid-fast bacteria)

Management information
Registered date	2021 Year 09 Month 22 Day
Last modified on	2021 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051999