UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022977 |
|---|---|
| Receipt number | R000026486 |
| Scientific Title | Imaging Findings for Predicting the Subtypes of Triple Negative Breast Cancers |
| Date of disclosure of the study information | 2016/07/26 |
| Last modified on | 2016/07/01 19:30:17 |
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Basic information
Public title
Imaging Findings for Predicting the Subtypes of Triple Negative Breast Cancers
Acronym
Imaging of Triple Negative Breast Cancers
Scientific Title
Imaging Findings for Predicting the Subtypes of Triple Negative Breast Cancers
Scientific Title:Acronym
Imaging of Triple Negative Breast Cancers
Region
| Japan |
Condition
Condition
Triple Negative Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We assess the utility of imaging findings of preoperative triple negative breast cancer retrospectively for predicting the clinicopathological subtypes of triple negative breast cancers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We assess the imaging findings of 18F-FDG PET/CT, breast MRI, and pathological diagnosis.
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
Those who PET/CT was performed at Tokyo Medical and Dental University Hospital during 2007/4/1 to 2016/3/31, and patholigical diagnosis was triple negative breast cancer.
Key exclusion criteria
None.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Kubota |
Organization
Medical Hospital, Tokyo Medical and Dental University
Division name
Department of Medical Informatics
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
kbtmrad@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Kubota |
Organization
Medical Hospital, Tokyo Medical and Dental University
Division name
Department of Diagnostic Radiology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
Homepage URL
kbtmrad@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 07 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study.
Management information
Registered date
| 2016 | Year | 07 | Month | 01 | Day |
Last modified on
| 2016 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026486
