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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023910
Receipt No. R000027533
Scientific Title Search of biomarkers related to the therapeutic effect of sublingual immunotherapy with epigenome analysis
Date of disclosure of the study information 2016/09/05
Last modified on 2018/06/19

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Basic information
Public title Search of biomarkers related to the therapeutic effect of sublingual immunotherapy with epigenome analysis
Acronym Epigenome analysis of the therapeutic effect of sublingual immunotherapy
Scientific Title Search of biomarkers related to the therapeutic effect of sublingual immunotherapy with epigenome analysis
Scientific Title:Acronym 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
1st name
Middle name
Last name Minoru Gotoh
Organization Nippon Medical School Tamanagayama Hospital
Division name Otorhinolaryngology
Zip code
Address 1-7-1 nagayama, tama-shi, tokyo
TEL 042-371-2111
Email m.gotoh@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Gotoh
Organization Nippon Medical School Tamanagayama Hospital
Division name Otorhinolaryngology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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