UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006126 |
|---|---|
| Receipt number | R000007248 |
| Scientific Title | A prospective multi-center study on sentinel node navigation surgery for early breast cancer patients |
| Date of disclosure of the study information | 2011/08/10 |
| Last modified on | 2011/08/06 12:23:01 |
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Basic information
Public title
A prospective multi-center study on sentinel node navigation surgery for early breast cancer patients
Acronym
Sentinel node navigation surgery in breast cancer
Scientific Title
A prospective multi-center study on sentinel node navigation surgery for early breast cancer patients
Scientific Title:Acronym
Sentinel node navigation surgery in breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm accuracy and feasibility of sentinel node navigation surgery (SNNS) using various tracers available in Japan, a prospective multi-center study was conducted for early breast cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification rate was compared among dye-guided, radioisotpe-guided, and combined SNNS.
Key secondary outcomes
adverse events and patient outcome during 5 years after registration would be observed.
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
sentinel node navigation surgery
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
T1-2 and clinically node- negative breast cancer
Key exclusion criteria
Clinically node-positive or T3 and more advanced breast cancer
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Imoto |
Organization
School of Medicine, Kyorin University
Division name
Department of Surgery
Zip code
Address
6-20-2 Shinkawa Mitaka Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Yana |
Organization
Japanese Society for Sentinel Node Navigation Surgery
Division name
Office
Zip code
Address
yanas@sc.itc.keio.ac.jp
TEL
Homepage URL
Sponsor or person
Institute
Japanese Society for Sentinel Node Navigation Surgery
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Sentinel Node Navigation Surgery
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
| 2011 | Year | 08 | Month | 10 | 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
| 2004 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 06 | Day |
Last modified on
| 2011 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007248
