UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008356
Receipt number R000009829
Scientific Title analysis of prognosis and blood test in patients with sudden deafness
Date of disclosure of the study information 2012/07/06
Last modified on 2012/07/05 14:42:00

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Basic information

Public title

analysis of prognosis and blood test in patients with sudden deafness

Acronym

blood test in patients with sudden deafness

Scientific Title

analysis of prognosis and blood test in patients with sudden deafness

Scientific Title:Acronym

blood test in patients with sudden deafness

Region

Japan


Condition

Condition

sudden deafness

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

we analyze the correlation between the blood tests and hearing prognosis.

Basic objectives2

Others

Basic objectives -Others

exploration of prognostic factor

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

hearing prognosis

Key secondary outcomes



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


Not applicable

Gender

Male and Female

Key inclusion criteria

sudden deafness

Key exclusion criteria

except sudden deafness

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sho Kanzaki

Organization

keio Univcersity School of Medicine

Division name

otolaryngology

Zip code


Address

35 Shinanomachi,Shinjuku

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Sho Kanzaki

Organization

Keio University, School of Medicine

Division name

otolaryngology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Sho Kanzaki

Institute

Department

Personal name



Funding Source

Organization

Keio university School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

2012 Year 07 Month 06 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

Suspended

Date of protocol fixation

2006 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 10 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

white blood cells correlated with hearing prognosis


Management information

Registered date

2012 Year 07 Month 05 Day

Last modified on

2012 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009829


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name