UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010861 |
|---|---|
| Receipt number | R000012714 |
| Scientific Title | A study of refractory chronic rhinosinusitis |
| Date of disclosure of the study information | 2013/06/03 |
| Last modified on | 2022/12/09 11:04:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of refractory chronic rhinosinusitis
Acronym
A study of refractory chronic rhinosinusitis
Scientific Title
A study of refractory chronic rhinosinusitis
Scientific Title:Acronym
A study of refractory chronic rhinosinusitis
Region
| Japan |
Condition
Condition
Chronic rhinosinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) is a heterogeneous disease. The majority of CRSwNP in western country is characterized by eosinophilic inflammation, but the pathogenesis of eosinophilic inflammation remains unclear.
Basic objectives2
Others
Basic objectives -Others
Chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) is a heterogeneous disease. The majority of CRSwNP in western country is characterized by eosinophilic inflammation, but the pathogenesis of eosinophilic inflammation remains unclear.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study is observational study. The aim of this study is to investigate immunological features in the pathogenesis of chronic rhinosinusitis.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with Chronic rhinosinusitis who will undergo an operation in Chiba university hospital and affiliates.
Key exclusion criteria
We exclude patients with HIV or hepatitis, or patients who received systemic steroids for at least 4 weeks before surgery
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Iinuma |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Otolaryngology
Zip code
2600856
Address
1-8-1 Inohana, Chuo-ku, Chiba,
TEL
0432227171
iinuma-t@chiba-u.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Iinuma |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Otolaryngology
Zip code
2600856
Address
Chiba chuoku inohana 1-8-1
TEL
0432227171
Homepage URL
iinuma-t@chiba-u.jp
Sponsor or person
Institute
Department of Otolaryngology
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
the grant from research on Allergic disease and Immunology of Health Labor Sciences Research Grant in Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine Ethics board
Address
Chiba chuou inohana 1-8-1
Tel
0432227171
igaku-rinri@office.chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background of patients
comobidity
symptoms
IgEs
leukotrienes
immunological features of cells in nasal polyps
cytokines in nasal polyps and serum
Management information
Registered date
| 2013 | Year | 06 | Month | 03 | Day |
Last modified on
| 2022 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012714
