UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020412 |
|---|---|
| Receipt number | R000023572 |
| Scientific Title | Association of serum and sputum resistin like molecule-beta(RELM-beta) with airway remodeling in bronchial asthma |
| Date of disclosure of the study information | 2015/12/31 |
| Last modified on | 2017/03/18 11:53:06 |
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Basic information
Public title
Association of serum and sputum resistin like molecule-beta(RELM-beta) with airway remodeling in bronchial asthma
Acronym
Association of serum and sputum resistin like molecule-beta(RELM-beta) with airway remodeling in bronchial asthma
Scientific Title
Association of serum and sputum resistin like molecule-beta(RELM-beta) with airway remodeling in bronchial asthma
Scientific Title:Acronym
Association of serum and sputum resistin like molecule-beta(RELM-beta) with airway remodeling in bronchial asthma
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the correlation between the concentration of sputum supernatant and serum RELM-beta and the index of airway wall thickness on chest CT in bronchial asthma
Basic objectives2
Others
Basic objectives -Others
To measure the correlation between the concentration of sputum supernatant and serum RELM-beta and the index of airway wall thickness on chest CT in bronchial asthma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between the concentration of sputum supernatant and serum RELM-beta and the index of airway wall thickness on chest CT in bronchial asthma
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Object: stable asthmatic patients
Control: patients undergoing routine chest CT for small nodules or small gland glass opacities in peripheral lung
(early lung cancer and atypical adenomatous hyperplasia) without airway disease such as asthma
Key exclusion criteria
If patients meet the following criteria, they are excluded.
Patients who
i. have respiratory tract infection or other respiratory disease within 4 weeks prior to enrollment
ii. have asthma attacks within 4 weeks prior to enrollment
iii. use anti-allergy drugs or inhaled anticholinergic drugs within 2 weeks prior to enrollment
iv. use systemic corticosteroids within 4 weeks prior to enrollment
v. currently smoke, had smoking history with 5 pack-years or more, or had quitted smoking within 6 months prior to the enrollment
vi. prepare for pregnancy, in pregnancy or breast-feeding
vii. unsuitable for the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Takemura |
Organization
Nagoya City University
Division name
Dept of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
Address
1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
m-take19@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroya Ichikawa |
Organization
Nagoya City University
Division name
Dept of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
Address
1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
Homepage URL
cartgreengreengreen@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2015 | Year | 12 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 18 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 18 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 18 | Day |
Other
Other related information
Design
cross-sectional study
Enrollment
patients who met the criteria of this study will be enrolled between Apr 2015 and Mar 2016
Measurement items
levels of RELM-beta in serum and sputum supernatant and indices of airway remodeling on chest CT
Management information
Registered date
| 2015 | Year | 12 | Month | 31 | Day |
Last modified on
| 2017 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023572
| 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 |
