UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037960 |
|---|---|
| Receipt number | R000042751 |
| Scientific Title | An etiological study on Japanese cedar and cypress pollen dispersion and antigen sensitization in Hiroshima |
| Date of disclosure of the study information | 2019/09/09 |
| Last modified on | 2020/09/07 13:03:05 |
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Basic information
Public title
An etiological study on Japanese cedar and cypress pollen dispersion and antigen sensitization in Hiroshima
Acronym
Japanese cedar and cypress pollen dispersion and antigen sensitization
Scientific Title
An etiological study on Japanese cedar and cypress pollen dispersion and antigen sensitization in Hiroshima
Scientific Title:Acronym
Japanese cedar and cypress pollen dispersion and antigen sensitization
Region
| Japan |
Condition
Condition
Cedar and cypress pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the relationship between dispersion rates of cedar and cypress pollens in Hiroshima and the antigen sensitization rate of the patients based on clinical records
Basic objectives2
Others
Basic objectives -Others
To examine trends of prevalence of patients with allergic disease for over the last 20 years
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Annual changes of the positive rate of antigen specific IgE levels against cedar and cypress
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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 had allergen blood tests
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Sachio |
| Middle name | |
| Last name | Takeno |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
7348551
Address
Kasumi 1-2-3, Minami-ku
TEL
0822575252
takeno@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Horibe |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
7348551
Address
Kasumi 1-2-3, Minami-ku
TEL
0822575252
Homepage URL
jibi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Center for Integrated Medical Research
Address
Kasumi 1-2-3, Minami-ku
Tel
082-257-1576
iryo-seisaku@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
EkiJu-3124
Org. issuing International ID_1
EkiJu-3124
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.hiroshima-u.ac.jp/system/files/125617/E-1738.pdf
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1000
Results
An increase in both the amounts and dispersion periods of Japanese cypress pollen as compared to that of cedar pollen tended to be observed in Hiroshima prefecture. The proportion of patients with positive ImmunoCAP scores increased for both cedar and cypress.
Results date posted
| 2020 | Year | 09 | Month | 07 | Day |
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
Main results already published
Date of protocol fixation
| 2019 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Dispersion counts of cedar and cypress pollens in Hiroshima Prefecture
Management information
Registered date
| 2019 | Year | 09 | Month | 07 | Day |
Last modified on
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042751
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
