UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012029 |
|---|---|
| Receipt number | R000014060 |
| Scientific Title | Prospective cohort study of Nontuberculous mycobacteriosis, especially M. intracelluare. |
| Date of disclosure of the study information | 2013/10/15 |
| Last modified on | 2021/10/08 08:24:14 |
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Basic information
Public title
Prospective cohort study of Nontuberculous mycobacteriosis, especially M. intracelluare.
Acronym
NTM registry
Scientific Title
Prospective cohort study of Nontuberculous mycobacteriosis, especially M. intracelluare.
Scientific Title:Acronym
NTM registry
Region
| Japan |
Condition
Condition
Nontuberculous mycobacteriosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surveillance of NTM, especially M. intracellulare.
Basic objectives2
Others
Basic objectives -Others
Surveillance of incidence, exacerbation, strain
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Surveillance of incidence, exacerbation, strain
Key secondary outcomes
Imaging, strain factor, QOL
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
1. Informed consent is obtained
2. Patient who was diagnosed of NTM, examined with Chest X-ray or Chest CT, and demonstrated M. intracelluare,
3. No history of treatment for M. intracelluare
Key exclusion criteria
1.Patient who is judged as an inappropriate case by the doctor in charge
2.Patient demonstrated other than M. intracellulare
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Masaki Fujita |
Organization
Fukuoka University
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
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
Fukuoka Mycobacteriosis Conference
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fukuoka University Hospital
Address
7-45-1 Nanakuma Jonanku, Fukoka
Tel
092-801-1011
rinshou@adm.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
九州大学病院呼吸器科（福岡県）
九州中央病院・呼吸器内科（福岡県）
済生会飯塚嘉穂病院・呼吸器内科（福岡県）
国立病院機構大牟田病院・呼吸器科（福岡県）
国立病院機構福岡病院・呼吸器科（福岡県）
国立病院機構福岡東医療センター・呼吸器科（福岡県）
西福岡病院・呼吸器内科（福岡県）
直方中央病院・呼吸器内科（福岡県）
浜の町病院・呼吸器科（福岡県）
原三信病院・呼吸器内科（福岡県）
福岡赤十字病院・呼吸器内科（福岡県）
福岡結核予防センター・呼吸器内科（福岡県）
福西会病院・呼吸器内科（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ongoing
Management information
Registered date
| 2013 | Year | 10 | Month | 14 | Day |
Last modified on
| 2021 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014060
| 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 |
