UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036426 |
|---|---|
| Receipt number | R000041507 |
| Scientific Title | Mycobacterium abscessus prospective registry |
| Date of disclosure of the study information | 2019/04/06 |
| Last modified on | 2024/04/15 08:21:35 |
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Basic information
Public title
Mycobacterium abscessus prospective registry
Acronym
Mycobacterium abscessus registry
Scientific Title
Mycobacterium abscessus prospective registry
Scientific Title:Acronym
Mycobacterium abscessus registry
Region
| Japan |
Condition
Condition
M. abscessus disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the relationship among strains factor, genetic factor, and clinical course in M. abscessus disease.
Basic objectives2
Others
Basic objectives -Others
Clinical course
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between 1-year clinical course and strain typing.
Key secondary outcomes
Relationship between 1-year clinical course and genetic factor
Clinical course depend on treatment
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
Diagnosed M. abscessus disease
Isolated M. abscessus
Submittable strains of M. abscessus
Informed consent
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Fujita |
Organization
Fukuoka University Hospital
Division name
Department of Respiratory Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonanku, Fukuoka
TEL
092-801-1011
mfujita@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Fujita |
Organization
Fukuoka University Hospital
Division name
Department of Respiratory Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonanku, Fukuoka
TEL
092-801-1011
Homepage URL
mfujita@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University 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
Fukuoka University - Medical Ethics Review Board
Address
7-45-1 Nanakuma, Jonanku, Fukuoka
Tel
092-801-1011
fu-merb-bigvan@fukuoka-u.ac.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
| 2019 | Year | 04 | Month | 06 | 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
| 2018 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2019 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041507
