UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006534
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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/
Email chie.watanabe0320@gmail.com

Sponsor
Institute Sentinel Lymph node biopsy following neoadjuvant chemotherapy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007486

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.