UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013550
Receipt number R000015832
Scientific Title Metagenome analysis of normal middle ear cavity
Date of disclosure of the study information 2014/04/01
Last modified on 2018/02/10 09:09:21

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Basic information

Public title

Metagenome analysis of normal middle ear cavity

Acronym

Metagenome analysis of normal middle ear cavity

Scientific Title

Metagenome analysis of normal middle ear cavity

Scientific Title:Acronym

Metagenome analysis of normal middle ear cavity

Region

Japan


Condition

Condition

non-infectous middle or inner ear disease

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify normal bacterial colony in the middle ear using metagenome

Basic objectives2

Others

Basic objectives -Others

To identify normal bacterial colony in the middle ear using metagenome

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

N/A

Key secondary outcomes

N/A


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

otosclerosis
auditory ossicular malformation
severe sensorineural hearing loss
bell's palsy
perilymph fistula

Key exclusion criteria

patients who do not give informed consent

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Oishi

Organization

Keio University School of Medicine

Division name

Otolaryngology- head and neck surgery

Zip code


Address

35 Shinanomachi, Shinjuku

TEL

03-5363-3827

Email

oishi_naoki@z5.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Oishi

Organization

Keio University School of Medicine

Division name

Otolaryngology- head and neck surgery

Zip code


Address

35 Shinanomachi, Shinjuku

TEL

03-5363-3827

Homepage URL


Email

oishi_naoki@z5.keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Other

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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2014 Year 03 Month 06 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Metagenome analysis


Management information

Registered date

2014 Year 03 Month 28 Day

Last modified on

2018 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015832


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name