UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021724 |
|---|---|
| Receipt number | R000025057 |
| Scientific Title | Influences of the huge earthquake-associated disaster on the clinical symptoms and radiographic findings in patients with non-tuberculous mycobacterium (NTM) |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2016/03/31 22:32:22 |
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Basic information
Public title
Influences of the huge earthquake-associated disaster on the clinical symptoms and radiographic findings in patients with non-tuberculous mycobacterium (NTM)
Acronym
Influences of the huge earthquake-associated disaster on the clinical symptoms and radiographic findings in patients with non-tuberculous mycobacterium (NTM)
Scientific Title
Influences of the huge earthquake-associated disaster on the clinical symptoms and radiographic findings in patients with non-tuberculous mycobacterium (NTM)
Scientific Title:Acronym
Influences of the huge earthquake-associated disaster on the clinical symptoms and radiographic findings in patients with non-tuberculous mycobacterium (NTM)
Region
| Japan |
Condition
Condition
non-tuberculous mycobacterium (NTM)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influences of the disaster on the non-tuberculous mycobacterium (NTM) disease state in the patients　who are living in the around areas of disasters.
Basic objectives2
Others
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
clinical symptoms and radiographic findings　before and after the disaster
Key secondary outcomes
association between stress disoder scores and NTM features after disasters
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patientsdiagnozed as NTM whom M. avium or M.intercellurare was identified from sputum culture
Patients lived in Japan at 11th March, 2011.
Key exclusion criteria
(1) Coexistence of other major pulmonary diseases such as asthma, bronchiectasis, pulmonary fibrosis, tuberculosis, and pulmonary cancer diagnosed by imaging modalities and/or laboratory findings. Asthma is excluded based on clinical history and/or laboratory findings, including levels of IgE and/or eosinophils in blood and/or sputum, but not based on reversibility of airflow limitation.
(2)patients with cancers
(3)patients with other serious complocations
(4) Those who are considered as inappropriate subjects for any reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Teramoto |
Organization
Hitachinaka General Hospital
Division name
Department of pulmonary medicine
Zip code
Address
20-1 Ishikawa-cho, Hitachinaka-shi, Ibaraki,Japan 312-0057
TEL
029-354-5111
shinjit-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Teramoto |
Organization
Hitachinaka General Hospital
Division name
Department of pulmonary medicine
Zip code
Address
20-1 Ishikawa-cho Hitachinaka-shi
TEL
029-354-5111
Homepage URL
shinjit-tky@umin.ac.jp
Sponsor or person
Institute
Hitachinaka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachinaka General 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
Address
Tel
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
| 2016 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 01 | Day |
Other
Other related information
The results will be presented in the Journals.
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2016 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025057
| 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 |
