UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045139 |
|---|---|
| Receipt number | R000051552 |
| Scientific Title | Pathological analysis of ECRS by RNA-seq |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/08/12 14:26:33 |
* 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
Pathological analysis of ECRS by RNA-seq
Acronym
R-ECRS
Scientific Title
Pathological analysis of ECRS by RNA-seq
Scientific Title:Acronym
R-ECRS
Region
| Japan |
Condition
Condition
eosinophilic chronic rhino sinusitis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
pathophysiological analyses of ECRS
Basic objectives2
Others
Basic objectives -Others
identification of biomarkers
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
identification of genes which are highly expressed in ECRS
Key secondary outcomes
identification of molecular pathways which are involved in the mechanisms of ECRS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
mepolizumab 100mg/4 weeks for 4 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients who are diagnosed as ECRS
2. patients who agree to be included in this trial by a document
3. patients who are older than 20 years old
4. patients who need surgery for his or her ECRS
Key exclusion criteria
1. patients who do not agree to be included in this trial
2. patients who have had mepolizumab therapy for his or her ECRS
3. patients who are not able to obtain his or her blood or surgical samples
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Hirose |
Organization
International University of Welfare and Health, Narita hospital
Division name
Department of Allergy and Rheumatology
Zip code
286-8520
Address
852 Hatage-ta, Narita city, Chiba
TEL
0476-35-5600
hirose-kh@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Hirose |
Organization
International University of Welfare and Health, Narita hospital
Division name
Department of Allergy and Rheumatology
Zip code
286-8520
Address
852 Hatage-ta, Narita city, Chiba
TEL
0476-35-5600
Homepage URL
hirose-kh@iuhw.ac.jp
Sponsor or person
Institute
International University of Welfare and Health, Narita hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education Culture, Sports Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Welfare and Health, Narita hospital
Address
852 Hatage-ta, Narita city, Chiba
Tel
0476-35-5600
hirose-kh@iuhw.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051552
