UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A diagnosis of neural degenerative disorders using primary cultured cells from olfactory mucosal tissue.
Title of the study (Brief title)	A diagnosis of neural degenerative disorders using primary cultured cells from olfactory mucosal tissue.
Region	Japan

Condition
Condition	Chronic sinusitis,Hypertrophic rhinitis,Deviation of nasal septum,Postoperative maxillary cyst
Classification by specialty	Neurology Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To diagnose of neural degenerative disorders using primary cultured cells from olfactory mucosal tissue
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Establishment of the culture method of olfactory mucosal cell
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Gene Maneuver
Interventions/Control_1	Sampling of olfactory mucosa at the time of endoscopic sinus surgery
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient who receives an endoscopic sinus surgery in chronic sinusitis, hypertrophic rhinitis,deviation of nasal septum,and postoperative maxillary cyst
Key exclusion criteria	none
Target sample size	20

Research contact person
Name of lead principal investigator	Takeshi Akisada
Organization	Kawasaki Medical School,Kawasaki Hospital
Division name	Otorhinolaryngology
Address	2-1-80,Nakasange,Kita-ku Okayama
TEL	0862252111
Email	akisada@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Takeshi Akisada
Organization	Kawasaki Medical School,Kawasaki Hospital
Division name	Otorhinolaryngology
Address	2-1-80,Nakasange,Kita-ku Okayama
TEL	0862252111
Homepage URL
Email	akisada@med.kawasaki-m.ac.jp

Sponsor
Institute	National Hospital Organization,Tottori Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization,Tottori Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 04 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 02 Month 14 Day
Anticipated trial start date	2014 Year 04 Month 14 Day
Last follow-up date	2016 Year 04 Month 13 Day
Date of closure to data entry	2016 Year 04 Month 13 Day
Date trial data considered complete	2016 Year 04 Month 13 Day
Date analysis concluded	2017 Year 04 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 14 Day
Last modified on	2018 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015340