UMIN-CTR Clinical Trial

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
Email	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
Email	morimotok@fukujuji.org

Sponsor
Institute	NTM-NET (NONTUBERCULOUS MYCOBACTERIA NETWORK EUROPOEAN TRIALGROUP)
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020785