UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007178 |
|---|---|
| Receipt number | R000008454 |
| Scientific Title | Exploratory analysis of risk factors for sensitization to Japanese cedar pollen |
| Date of disclosure of the study information | 2012/01/31 |
| Last modified on | 2012/01/31 13:49:52 |
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Basic information
Public title
Exploratory analysis of risk factors for sensitization to Japanese cedar pollen
Acronym
Exploring several predictable risk factors for sensitization to Japanese cedar pollen
Scientific Title
Exploratory analysis of risk factors for sensitization to Japanese cedar pollen
Scientific Title:Acronym
Exploring several predictable risk factors for sensitization to Japanese cedar pollen
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring several predictable biomarkers for sensitization to Japanese cedar pollen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lymphocyte Subsets of Peripheral Blood Mononuclear Cells to the Japanese cedar pollen
Key secondary outcomes
Lymphocyte Subsets of Peripheral Blood Mononuclear Cells to the Mite Antigens
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Negative specific IgE to Japanese cedar pollen (CAP-RAST<=class1).
Key exclusion criteria
1) Perennial allergic rhinitis with more than moderate symtom.
2)Patients who is being treated with anti-histamine,anti-allergic drugs and steroid.
3)Complication of the other nasal-paranasal disease and fungal infections.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syuji Yonekura |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
Homepage URL
Sponsor or person
Institute
Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
千葉大学大学院医学研究院 耳鼻咽喉科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 04 | Month | 01 | Day |
Other
Other related information
(1)prospective observational study
(2)Relationship between the observed factors and the results
Management information
Registered date
| 2012 | Year | 01 | Month | 31 | Day |
Last modified on
| 2012 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008454
