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
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
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
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
