UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054636 |
|---|---|
| Receipt number | R000062434 |
| Scientific Title | Study of cedar pollen-specific s-IgA in pollinosis patients and healthy subjects |
| Date of disclosure of the study information | 2024/06/12 |
| Last modified on | 2025/03/17 19:25:47 |
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Basic information
Public title
Study of cedar pollen-specific s-IgA in pollinosis patients and healthy subjects
Acronym
Study of cedar pollen-specific s-IgA in pollinosis patients and healthy subjects
Scientific Title
Study of cedar pollen-specific s-IgA in pollinosis patients and healthy subjects
Scientific Title:Acronym
Study of cedar pollen-specific s-IgA in pollinosis patients and healthy subjects
Region
| Japan |
Condition
Condition
pollinosis patients and subjects without allergic disease
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of various immunoglobulins between pollinosis patients and subjects without allergic disease
Basic objectives2
Others
Basic objectives -Others
Basic research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Specific IgE antibody (cedar), nonspecific IgE antibody, SBP-specific IgG4, SBP-specific IgA, salivary secretory IgA (Total, SBP-specific)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 64 years of age
(2) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
(3) Subjects who meet any of the following criteria
a) Subjects with hay fever symptoms during the pollen dispersal period, positive for specific IgE (cedar) (class 2 or higher), and diagnosed as having moderate or higher hay fever by a physician
b) Subjects who have no reported allergic disease and whose specific IgE (cedar) is less than false positive (class 1) and whose nonspecific IgE antibodies are less than or equal to the reference value
Key exclusion criteria
(1) Subjects who used steroid medication within 4 weeks prior to the test
(2) Subjects who have difficulty restricting the use of medications that may affect nasal or eye discomfort for one month prior to the test
(3) Subjects with bronchial asthma
(4) Subjects who have received specific or non-specific immunotherapy in the past
(5) Subjects who have problems or diseases involving bleeding in the oral cavity or who are undergoing dental treatment
(6) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey
(7) Subjects who are judged as unsuitable for the study based on the results of the test
(8) Subjects who are judged as unsuitable for the study by the principal investigator or the investigator for other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Yamamoto |
Organization
EPS Innovative Medicine (Japan) Co., Ltd.
Division name
Research Center
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-4220-8274
yamamoto.tetsuro061@eps.co.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Shimada |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
090-5219-2774
Homepage URL
shimada.hiroyasu767@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EPS Innovative Medicine (Japan) Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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
医療法人社団順風会 玄耳鼻咽喉科院(GEN E.N.T. CLINIC) (千葉県)、医療法人社団左門ふたば会 ふたばクリニック（Futaba Clinic）（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 12 | 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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of various immunoglobulins between pollinosis patients and subjects without allergic disease
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062434
