UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052699 |
|---|---|
| Receipt number | R000060134 |
| Scientific Title | Study of introduction of biological agents for refractory sinusitis |
| Date of disclosure of the study information | 2023/11/06 |
| Last modified on | 2023/11/05 16:22:47 |
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Basic information
Public title
Study of treatment for refractory sinusitis
Acronym
Treatment for refractory sinusitis
Scientific Title
Study of introduction of biological agents for refractory sinusitis
Scientific Title:Acronym
Introduction of biological agents for refractory sinusitis
Region
| Japan |
Condition
Condition
chronic sinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the suitability and safety of biological agents for chronic sinusitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of surgical indications
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with chronic sinusitis
2)Patients with bilateral chronic sinusitis
Key exclusion criteria
1)Patients who have refused to use their data
2)Patients undergoing treatment for malignant tumor.
3) Patients who are judged by the research director to be inappropriate as research subjects.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Nakamura |
Organization
Tottori University Hospital
Division name
Otolaryngology, Head and Neck Surgery
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago
TEL
0859-38-6627
yosuken@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nakamura |
Organization
Tottori University Hospital
Division name
Otolaryngology, Head and Neck Surgery
Zip code
6838504
Address
36-1, Nishi-cho, Yonago
TEL
0859-38-6627
Homepage URL
yosuken@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Education
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
Research cooperation section
Address
36-1, Nishi-cho, Yonago
Tel
0859-33-1111
me-kenkyu@ml.adm.tottori-u.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
| 2023 | Year | 11 | Month | 06 | 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
Suspended
Date of protocol fixation
| 2021 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sinusitis recurrence rate
Administration methods and safety of biological products
Presence of asthma
Management information
Registered date
| 2023 | Year | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060134
