UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039895 |
|---|---|
| Receipt number | R000044953 |
| Scientific Title | Examination of local IgE and follicular dendritic cells in the endtype of eosinophilic chronic rhinosinusitis. |
| Date of disclosure of the study information | 2020/03/22 |
| Last modified on | 2020/03/21 16:46:08 |
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Basic information
Public title
Examination of local IgE and follicular dendritic cells in the endtype of eosinophilic chronic rhinosinusitis.
Acronym
Local IgE and FDC in eosinophilic chronic rhinosinusitis
Scientific Title
Examination of local IgE and follicular dendritic cells in the endtype of eosinophilic chronic rhinosinusitis.
Scientific Title:Acronym
Local IgE and FDC in eosinophilic chronic rhinosinusitis
Region
| Japan |
Condition
Condition
eosinophilic chronic rhinosinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pathological analysis of local IgE antibody production in eosinophilic sinusitis
Basic objectives2
Others
Basic objectives -Others
Pathological analysis of follicular dendritic cells in eosinophilic sinusitis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparative study of local IgE antibody production in pathological findings of eosinophilic sinusitis
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CRS with polyp
Key exclusion criteria
Dental sinusitis
Sinus mycosis
Sinus tumor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | wakayama |
| Middle name | |
| Last name | nozomu |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Otolaryngology
Zip code
211-0063
Address
1-396 Kosugimachi, Nakahara-ku kawasaki kanagawa Prefecture
TEL
0447335181
waka84@nms.ac.jp
Public contact
Name of contact person
| 1st name | wakayama |
| Middle name | |
| Last name | nozomu |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Otolaryngology
Zip code
211-0063
Address
1-396 Kosugimachi, Nakahara-ku kawasaki kanagawa Prefecture
TEL
0447335181
Homepage URL
waka84@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Kawasaki-shi
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Musashikosugi Hospital
Address
1-396 Kosugimachi, Nakahara-ku, kawasaki, kanagawa
Tel
0447335181
waka84@nms.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
| 2020 | Year | 03 | Month | 22 | 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
40
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
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
np
Management information
Registered date
| 2020 | Year | 03 | Month | 21 | Day |
Last modified on
| 2020 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044953
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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