UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003054 |
|---|---|
| Receipt number | 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 09:08:02 |
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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
| Obstetrics 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
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
mhori@radiol.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003706
