UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006534 |
|---|---|
| Receipt number | R000007486 |
| Scientific Title | Feasibility study of sentinel lymph node biopsy following neoadjuvant chemotherapy in breast cancer patients |
| Date of disclosure of the study information | 2011/10/30 |
| Last modified on | 2015/04/16 01:41:51 |
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Basic information
Public title
Feasibility study of sentinel lymph node biopsy following neoadjuvant chemotherapy in breast cancer patients
Acronym
Feasibility study of sentinel lymph node biopsy following neoadjuvant chemotherapy in breast cancer patients
Scientific Title
Feasibility study of sentinel lymph node biopsy following neoadjuvant chemotherapy in breast cancer patients
Scientific Title:Acronym
Feasibility study of sentinel lymph node biopsy following neoadjuvant chemotherapy in breast cancer patients
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of SLNB following NAC in patients for whom lymph node metastasis was changed from positive to negativefollowing NAC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
False-negative rate
Key secondary outcomes
Idenfication rate
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Sentinel lymph node biopsy
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
Male and Female
Key inclusion criteria
1.Histologically proven breast cancer.
2.TNM classification is T1-T3 and N1,M0.
3.Axillary lymph nodes metastasis was detected by fine needle aspiration biopsy before NAC.
4.NAC was performed.
5.Axillary lymph nodes metastasis was comfirmed to change negative by biopsy orUS after NAC.
6.Axillary lymph node dissection will be performed after SLNB.
7.Patients aged 20 and over years old.
8.ECOG performance status (PS) of 0or1.
9.Sufficient organ functions.
10.Witten informed consent.
Key exclusion criteria
1.History of undergo sentinel lymph node biopsy
2.Ipsilateral breast tumor recurrence
3.Inflammatory breast cancer
4.Bilateral breast cancer
5.Women during pregnancy or breast-feeding.
6.Disqualified by doctors
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Nakamura |
Organization
Showa University hospital
Division name
Breast Center
Zip code
Address
1-5-8, hatanodai, shinagawaku, Tokyo, japan
TEL
03-3784-8727
chiew@medshowa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Watanabe |
Organization
Showa University hospital
Division name
Breast Center
Zip code
Address
1-5-8, hatanodai, shinagawaku, Tokyo, japan
TEL
03-3784-8727
Homepage URL
http://jpsnb.net/
chie.watanabe0320@gmail.com
Sponsor or person
Institute
Sentinel Lymph node biopsy following neoadjuvant chemotherapy
Institute
Department
Personal name
Funding Source
Organization
a Grant-in-Aid for Cancer Research from the Ministry of Health, Labor and Welfare
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
http://jpsnb.net/
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
| 2011 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | 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 | 10 | Month | 13 | Day |
Last modified on
| 2015 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007486
| 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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