UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008153 |
|---|---|
| Receipt number | R000009598 |
| Scientific Title | A prospective comparison between CT and MRI imaging for diagnostic accuracies of rectal cancer |
| Date of disclosure of the study information | 2012/06/12 |
| Last modified on | 2016/06/24 21:38:56 |
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Basic information
Public title
A prospective comparison between CT and MRI imaging for diagnostic accuracies of rectal cancer
Acronym
A prospective comparison between CT and MRI imaging for diagnostic accuracies of rectal cancer
Scientific Title
A prospective comparison between CT and MRI imaging for diagnostic accuracies of rectal cancer
Scientific Title:Acronym
A prospective comparison between CT and MRI imaging for diagnostic accuracies of rectal cancer
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare
the diagnostic accuracy between MRI and MDCT for the local staging of rectal cancer that was confirmed based on the histopathologic findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity, specificity, positive predictive value(PPV), negative predictive value (NPV), the area under the ROC curve (AUC) and accuracy of the modified T and N staging for rectal cancer between the MRI and CT
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
rectal cancer
Key exclusion criteria
non-operative case
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Miyakura |
Organization
Jichi Medical University
Division name
Surgery
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7371
miyakura@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Miyakura |
Organization
Jichi Medical University
Division name
Surgery
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7371
Homepage URL
miyakura@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Jichi Medical University
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
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
| 2012 | Year | 06 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Depth of tumor invasion and lymph node metastasis of rectal cancer by CT and MRI
Management information
Registered date
| 2012 | Year | 06 | Month | 12 | Day |
Last modified on
| 2016 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009598
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
