UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005315 |
|---|---|
| Receipt number | R000006318 |
| Scientific Title | Feasibility study of Axillary Reverse Mapping using by Computed tomography for breast cancer with clinical negative node |
| Date of disclosure of the study information | 2011/03/25 |
| Last modified on | 2011/09/25 10:42:40 |
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Basic information
Public title
Feasibility study of Axillary Reverse Mapping using by Computed tomography for breast cancer with clinical negative node
Acronym
CTLG-ARM
Scientific Title
Feasibility study of Axillary Reverse Mapping using by Computed tomography for breast cancer with clinical negative node
Scientific Title:Acronym
CTLG-ARM
Region
| Japan |
Condition
Condition
clinically node negative breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of ARM using by CTLG for clinically node negative breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
detection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
contrast enhanced CT
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
breast cancer
clinically node negative
Key exclusion criteria
clinically node positive
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanobu Sato |
Organization
Tokyo Medical and Dental University
Division name
Department of Breast Surgery
Zip code
Address
1-5-45 Yushima Bunkyo-ku,Tokyo
TEL
03-3813-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kuwayama |
Organization
Tokyo Medical and Dental University
Division name
Department of Breast Surgery
Zip code
Address
1-5-45 Yushima Bunkyo-ku,Tokyo
TEL
03-3813-6111
Homepage URL
kuwayama.srg2@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Department of Breast Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
東京医科歯科大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 25 | 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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | 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
Management information
Registered date
| 2011 | Year | 03 | Month | 25 | Day |
Last modified on
| 2011 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006318
| 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 |
