UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000037960
Receipt No. 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 (Ver. 4)

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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
Email 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
Email jibi@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042751