UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034120 |
|---|---|
| Receipt number | 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 17:07:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sayuriya@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.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 |
