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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044547


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name