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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003054
Receipt No. R000003706
Scientific Title MR imaging of endometrial carcinoma for preoperative staging: a prospective study
Date of disclosure of the study information 2010/01/18
Last modified on 2012/07/18

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Basic information
Public title MR imaging of endometrial carcinoma for preoperative staging: a prospective study
Acronym MR imaging of endometrial carcinoma for preoperative staging
Scientific Title MR imaging of endometrial carcinoma for preoperative staging: a prospective study
Scientific Title:Acronym MR imaging of endometrial carcinoma for preoperative staging
Region
Japan

Condition
Condition endometrial carcinoma of the uterus
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To prospectively compare magnetic resonance imaging (MRI) at 3.0 T for preoperative evaluation of endometrial carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Local-regional staging of endometrial carcinoma
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 Female
Key inclusion criteria 1) the presence of endometrial adenocarcinoma histologically documented, 2) no previous treatment for the disease, 3) surgical candidates
Key exclusion criteria 1) contraindication to MRI, 2) High quality MR imaging has already undergone at other hospitals, 3) unable to obtain informed consent, 4) below the age of 20, 5) contraindication to surgery
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Hori
Organization Osaka University Hospital
Division name Dept of Radiology
Zip code
Address 2-2, Yamadaoka, Suita-city, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Hori
Organization Osaka University
Division name Medical School
Zip code
Address
TEL
Homepage URL
Email mhori@radiol.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Osaka University
Organization
Division
Category of Funding Organization
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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 18 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 Completed
Date of protocol fixation
2010 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 02 Month 28 Day
Date of closure to data entry
2012 Year 02 Month 28 Day
Date trial data considered complete
2012 Year 03 Month 08 Day
Date analysis concluded
2012 Year 03 Month 30 Day

Other
Other related information A prospective study to evaluate MRI for preoperative staging of endometrial carcinoma

Management information
Registered date
2010 Year 01 Month 18 Day
Last modified on
2012 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003706

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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