UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035138
Receipt number R000040050
Scientific Title Evaluation of the precision in image diagnosis of cholesteatoma
Date of disclosure of the study information 2018/12/04
Last modified on 2020/06/17 00:32:22

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Basic information

Public title

Evaluation of the precision in image diagnosis of cholesteatoma

Acronym

Image diagnosis of cholesteatoma

Scientific Title

Evaluation of the precision in image diagnosis of cholesteatoma

Scientific Title:Acronym

Image diagnosis of cholesteatoma

Region

Japan


Condition

Condition

cholesteatoma

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the precision in fusion images of CT and MRI

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Precision in diagnosis of cholesteatoma by fusion images of CT and MRI

Key secondary outcomes

diagnosis in each part of middle ear


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

patients who undergo planned tympanoplasty for cholesteatoma

Key exclusion criteria

patients who cannot undergo MRI
patients who are judged unsutable for this study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yumi
Middle name
Last name Ohta

Organization

Osaka university

Division name

otorhinolaryngology and head and neck surgery

Zip code

5650871

Address

2-2 Yamadaoka Suita Osaka, Japan

TEL

06-6879-3951

Email

yota@ent.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Yumi
Middle name
Last name Ohta

Organization

Osaka University

Division name

otorhinolaryngology and head and neck surgery

Zip code

5650871

Address

2-2 Yamadaoka Suita Osaka, Japan

TEL

06-6879-3951

Homepage URL


Email

yota@ent.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka university

Institute

Department

Personal name



Funding Source

Organization

none

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

Academic Clinical Research Center of Osaka University Hospital

Address

2-2 Yamadaoka Suita, Osaka

Tel

06-6210-8290

Email

jim-chiken@hp-crc.med.osaka-u.ac.jp


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

大阪大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 04 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

Enrolling by invitation

Date of protocol fixation

2017 Year 07 Month 04 Day

Date of IRB

2017 Year 07 Month 04 Day

Anticipated trial start date

2017 Year 07 Month 04 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

continue enrolling in this study


Management information

Registered date

2018 Year 12 Month 04 Day

Last modified on

2020 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040050


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name