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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025782
Receipt No. R000029651
Scientific Title MR imaging for differentiating between Warthin tumor and oncocytoma of the parotid gland
Date of disclosure of the study information 2017/02/01
Last modified on 2017/01/21

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Basic information
Public title MR imaging for differentiating between Warthin tumor and oncocytoma of the parotid gland
Acronym MR imaging for differentiating between Warthin tumor and oncocytoma of the parotid gland
Scientific Title MR imaging for differentiating between Warthin tumor and oncocytoma of the parotid gland
Scientific Title:Acronym MR imaging for differentiating between Warthin tumor and oncocytoma of the parotid gland
Region
Japan

Condition
Condition Warthin tumor
oncocytoma
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of MR imaging for differentiating between Warthin tumor and oncocytoma of the parotid gland.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the differences in MR imaging findings including location, signal intensity, and ADC value between Warthin tumor and oncocytoma.
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
45 years-old <=
Age-upper limit
83 years-old >=
Gender Male and Female
Key inclusion criteria patients with histopathologically proven Warthin tumor or oncocytoma of the parotid gland
Key exclusion criteria patients who did not undergo preoperative MR imaging, including DW imaging
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Kato
Organization Gifu University School of Medicine
Division name Radiology
Zip code
Address 1-1 Yanagido, Gifu 501-1194, Japan
TEL 058-230-6439
Email hkato@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Kato
Organization Gifu University School of Medicine
Division name Radiology
Zip code
Address 1-1 Yanagido, Gifu 501-1194, Japan
TEL 058-230-6439
Homepage URL
Email hkato@gifu-u.ac.jp

Sponsor
Institute Gifu University School of Medicine
Institute
Department

Funding Source
Organization Gifu University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 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
2016 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 01 Month 21 Day
Last modified on
2017 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029651

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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