UMIN-CTR Clinical Trial

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
Email	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
Email	muradai@med.kyushu-u.ac.jp

Sponsor
Institute	Graduate School of Medical Sciences, Kyushu University Otorhinolaryngology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044547