UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Search of biomarkers related to the therapeutic effect of sublingual immunotherapy with epigenome analysis
Title of the study (Brief title)	Epigenome analysis of the therapeutic effect of sublingual immunotherapy
Region	Japan

Condition
Condition	Japanese cedar pollinosis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the floor of the mouth as mucosal immune induction organization of sublingual immunotherapy, it is considered to be the important need to analyze the relevance of the oral flora and intestinal flora and epigenome gene as an environmental factor. This study was aimed to elucidate the successful mechanism and high efficiency induction development of sublingual immunotherapy in personalized medicine that is appropriate to the individual patient.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Epigenome analysis of before and after treatment
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	sublingual immunotherapy for cedar pollinosis
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 subjects who wish to treatment of sublingual immunotherapy in health care in the adaptation's cedar pollen sublingual immunotherapy of IgE antibody-positive against cedar pollen
Key exclusion criteria	Exclusion criteria included severe asthma cases or malignant tumors, such as collagen disease merger example, it is contraindicated patients with sublingual immunotherapy therapeutic agent Shidatoren.
Target sample size	50

Research contact person
Name of lead principal investigator	Minoru Gotoh
Organization	Nippon Medical School Tamanagayama Hospital
Division name	Otorhinolaryngology
Address	1-7-1 nagayama, tama-shi, tokyo
TEL	042-371-2111
Email	m.gotoh@nms.ac.jp

Public contact
Name of contact person	Minoru Gotoh
Organization	Nippon Medical School Tamanagayama Hospital
Division name	Otorhinolaryngology
Address	1-7-1 nagayama, tama-shi, tokyo
TEL	042-371-2111
Homepage URL
Email	m.gotoh@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 09 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 31 Day
Anticipated trial start date	2016 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 09 Month 02 Day
Last modified on	2018 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027533