UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013541 |
|---|---|
| Receipt number | R000015821 |
| Scientific Title | Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases. |
| Date of disclosure of the study information | 2014/03/27 |
| Last modified on | 2018/10/04 15:05:40 |
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Basic information
Public title
Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases.
Acronym
Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases.
Scientific Title
Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases.
Scientific Title:Acronym
Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases.
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
bronchial asthma
sarcoidosis
interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate correlation between respiratory mechanics and anatomical structure of lungs in patients with chronic lung diseases.
Basic objectives2
Others
Basic objectives -Others
correlation analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
respiratory resistance
respiratory reactance
luminal area of airway
wall thickness or airway
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed with COPD, bronchial asthma, sarcoidosis, or interstitial lung disease.
Patients who gave written informed consent.
Key exclusion criteria
Patients who could not underwent forced oscillation test or chest computed tomography.
Patients who did not give written informed consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu Univ. School of Medicine
Division name
Second devision, department of internal medicine
Zip code
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref.
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Karayama |
Organization
Hamamatsu Univ. School of Medicine
Division name
Second devision, department of internal medicine
Zip code
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref.
TEL
053-435-2263
Homepage URL
karayama@hama-med.ac.jp
Sponsor or person
Institute
Second devision, department of internal medicine, Hamamatsu Univ. School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second devision, department of internal medicine, Hamamatsu Univ. School of Medicine
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
| 2014 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective random sampling
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015821
