UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045542 |
|---|---|
| Receipt number | R000051999 |
| Scientific Title | Prospective, observational study on diagnosis and treatment of Mycobacterium avium complex pulmonary disease in a clinical practice covered by Japanese healthcare insurance |
| Date of disclosure of the study information | 2021/09/22 |
| Last modified on | 2021/09/22 16:02:40 |
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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
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
mae.ryoji@gmail.com
Sponsor or person
Institute
National Hospital Organization Osaka Toneyama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051999
