UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017930 |
|---|---|
| Receipt number | R000020785 |
| Scientific Title | Multinational comparison analysis using quantitative radiological evaluation in MAC pulmonary disease (MACPD) |
| Date of disclosure of the study information | 2015/06/17 |
| Last modified on | 2020/06/19 10:49:58 |
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Basic information
Public title
Multinational comparison analysis using quantitative radiological evaluation in MAC pulmonary disease (MACPD)
Acronym
Quantitative radiological evaluation in MACPD
Scientific Title
Multinational comparison analysis using quantitative radiological evaluation in MAC pulmonary disease (MACPD)
Scientific Title:Acronym
Quantitative radiological evaluation in MACPD
Region
| Japan | Asia(except Japan) | North America |
| Australia | Europe |
Condition
Condition
Mycobacterium avium complex pulmonary disease (MAC-PD)
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to reveal the relation between clinical cure, radiological cure and microbiological cure and to clarify the ability to predict who will be cured based on CT scoring system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will detect the change of the severity scores of MAC diseases by chest X-ray and CT scan, before and after 12 months of therapy, from cases in 3 or more countries.
Key secondary outcomes
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
Adult patients with MACPD (i.e. microbiologically confirmed M. avium or M. intracellulare) from each country that were diagnosed according to 2007 ATS/IDSA guideline since 2007. Chest X-ray and plain CT that have been performed each before and one year and optionally 6 months after starting a standard treatment recommended by the ATS/IDSA will be collected.
Key exclusion criteria
HIV-1 positive or patients taking immunosuppressive drugs. Under 18 year-old. Clarithromycin resistant case.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kozo |
| Middle name | |
| Last name | Morimoto |
Organization
Fukujuji Hospital,
Japan Anti-Tuberculosis Association
Division name
Respiratory Disease Center
Zip code
204-8522
Address
3-1-24 Matsuyama 204-8522 Kiyose-shi, Tokyo, Japan
TEL
81-42-491-4111
morimotok@fukujuji.org
Public contact
Name of contact person
| 1st name | Kozo |
| Middle name | |
| Last name | Morimoto |
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Division name
Respiratory Disease Center
Zip code
204-8522
Address
3-1-24 Matsuyama 204-8522 Kiyose-shi, Tokyo, Japan
TEL
81-42-491-4111
Homepage URL
morimotok@fukujuji.org
Sponsor or person
Institute
NTM-NET (NONTUBERCULOUS MYCOBACTERIA NETWORK EUROPOEAN TRIALGROUP)
Institute
Department
Personal name
Funding Source
Organization
none
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
Fukujuji Hospital
Address
3-1-24. Matsuyama Kiyose-city
Tel
0424914111
bxypb621@ybb.ne.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 17 | 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
80
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
| 2015 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrolling by Invitation
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2020 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020785
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
