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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000034120
Receipt No. R000038896
Scientific Title immunosuppressive function in patient with eosinophilic chronic rhinosinusitis
Date of disclosure of the study information 2018/11/01
Last modified on 2018/12/12

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Basic information
Public title immunosuppressive function in patient with eosinophilic chronic rhinosinusitis
Acronym eosinophilic chronic rhinosinusitis
Scientific Title immunosuppressive function in patient with eosinophilic chronic rhinosinusitis
Scientific Title:Acronym eosinophilic chronic rhinosinusitis
Region
Japan

Condition
Condition eosinophilic chronic rhinosimusitis
chronic rhinosinusitis
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The role of Regulatory T cells in nasal mucosa in ECRS patient
Patterns of IL-27 and anti-inflammatory cytokines including IL-10 and IL-35 in ECRS patient
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Concentration of cytokines related to eosinophipic inflammation including IL-10, IL-27, IL-35, IFN-gammma, and TGF-beta in nasal mucosa
Populaton of lymphocytes, mainly regarding to regulatory T cells
Key secondary outcomes Percentage of eosinophils in peripherary blood
Past history, Especially Asthma

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
16 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who are undergone endoscopic sinus surgery for their disease of rhinosinus at otorhinolaryngology department in Shiga University of Medical Science
Key exclusion criteria Patients who do not agree because of their paticular reason including dimentia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouzaki Hideaki
Organization Shiga University of Medical Science
Division name Otorhinolaryngology department
Zip code
Address Tsukinowa-cho, Seta, Otsu-shi, Shiga-ken
TEL 077-548-2111
Email sayuriya@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamamoto Sayuri
Organization Shiga University of Medical Science
Division name Otorhinolaryngology department
Zip code
Address Tsukinowa-cho, Seta, Otsu-shi, Shiga-ken
TEL 077-548-2111
Homepage URL
Email sayuriya@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Shiga University of Medical Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 11 Month 01 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 Terminated
Date of protocol fixation
2018 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 29 Day
Last follow-up date
2018 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information not paticular

Management information
Registered date
2018 Year 09 Month 13 Day
Last modified on
2018 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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