UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008847 |
|---|---|
| Receipt number | R000010389 |
| Scientific Title | A multicenter observational study on "One airway, One disease" from the perspective of rhinosinusitis. |
| Date of disclosure of the study information | 2012/09/05 |
| Last modified on | 2017/03/10 08:55:28 |
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Basic information
Public title
A multicenter observational study on "One airway, One disease" from the perspective of rhinosinusitis.
Acronym
"One airway, One disease" from the perspective of rhinosinusitis.
Scientific Title
A multicenter observational study on "One airway, One disease" from the perspective of rhinosinusitis.
Scientific Title:Acronym
"One airway, One disease" from the perspective of rhinosinusitis.
Region
| Japan |
Condition
Condition
Chronic rhinosinusitis
Eosinophilic otitis media
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To investigate co-morbid lower respiratory tract diseases with both eosinophilic otitis media and each subclass of chronic rhinosinusitis.
(2) To evaluate the effect of sinus surgery on asthmatic condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of co-morbid lower respiratory tract diseases with both eosinophilic otitis media and each subclass of chronic rhinosinusitis.
Key secondary outcomes
Evaluation of the effect of sinus surgery on asthmatic condition.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients who had undergone the sinus surgery (ESS)
(2)Patients with eosinophilic otitis media
Key exclusion criteria
None
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Sakuma |
Organization
Yokohama City University Medical Center
Division name
Department of Otorhinolaryngology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
ishitoya@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Sakuma |
Organization
Yokohama City University Medical Center
Division name
Department of Otorhinolaryngology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
ysakuma@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yokohama City University Medical Center,Respiratory Disease Center
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
横浜市立大学附属市民総合医療センター(神奈川県）
横浜市立大学附属病院(神奈川県）
藤沢市民病院(神奈川県）
横浜南共済病院(神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The evaluation of lower respiratory disease is performed by specialists in respiratory tract diseases.
The evaluation for the effect of sinus surgery on asthmatic condition is a cohort study for one year after the surgery.
Management information
Registered date
| 2012 | Year | 09 | Month | 04 | Day |
Last modified on
| 2017 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010389
