UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039137 |
|---|---|
| Receipt number | R000044547 |
| Scientific Title | Genetic analysis for eosinophilic sinusitis and construction of its database |
| Date of disclosure of the study information | 2020/01/15 |
| Last modified on | 2020/01/13 11:10:47 |
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Basic information
Public title
Genetic analysis for eosinophilic sinusitis and construction of its database
Acronym
Genetic analysis for eosinophilic sinusitis
Scientific Title
Genetic analysis for eosinophilic sinusitis and construction of its database
Scientific Title:Acronym
Genetic analysis for eosinophilic sinusitis
Region
| Japan |
Condition
Condition
Eosinophilic sinusitis
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Search for genetic information from tissues and blood from patients with eosinophilic sinusitis.
Basic objectives2
Others
Basic objectives -Others
Identification of recurrence prediction markers,and identification of novel genes or molecules as therapeutic targets.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Genes and molecules assosiated with disease occurrence and prognosis
Key secondary outcomes
Predictive markers for recurrence,and novel molecules targeted for treatment
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with eosinophilic sinusitis by score and histopathology
Key exclusion criteria
Those currently receiving immunotherapy. Patients who have taken steroid oral treatment, or who have taken oral steroid therapy or infusion therapy within one month, those who have used steroid-containing immunosuppressants, or those who have used them within one month. Pregnant ones. Those who are cancer-carrying patients.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Otorhinolaryngology
Zip code
812-8582
Address
Maidashi 3-1-1 Higashi-ku, Fukuoka 812-8582, Japan
TEL
0926425668
nakataka@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | daisuke |
| Middle name | |
| Last name | murakami |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Otorhinolaryngology
Zip code
812-8582
Address
Maidashi 3-1-1 Higashi-ku, Fukuoka 812-8582, Japan
TEL
0926425668
Homepage URL
muradai@med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kyushu University
Otorhinolaryngology
Institute
Department
Personal name
Funding Source
Organization
The Soda Toyoji Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital
Address
Maidashi 3-1-1 Higashi-ku, Fukuoka 812-8582, Japan
Tel
0926425774
bynintei@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
782-00
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare eosinophilic sinusitis with other sinusitis (mainly bacterial sinusitis) and search for genetic information, differences in expressed molecules, prognostic factors, and biomarkers related to prognosis.
Management information
Registered date
| 2020 | Year | 01 | Month | 13 | Day |
Last modified on
| 2020 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044547
