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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023435
Receipt No. R000026489
Scientific Title A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Date of disclosure of the study information 2016/08/30
Last modified on 2016/08/01

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Basic information
Public title A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Acronym A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Scientific Title A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Scientific Title:Acronym A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the safety of omitting axillary dissection in patients with breast cancer and one to two postive sentinel nodes.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5year axillary recurrence rate
Key secondary outcomes 1)Overall survival
2)recurrence-free suvival
3)local recurrence-free suvival
4)the rate of upper-limb lymphedema
5)Quality of life
6)comparison of axillary recurrence rate between patients with two or more nodes dissected and only one positive node and those with other situation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 to omit axillary dissection for patients
with one to two positve sentinel lymph nodes
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 1) diagnosed as breast cancer by core needle/vacuum assisted biopsy
2)clinical N0
3)planned to undergo lumpectomy and radiation therapy
4)written informed consent
Key exclusion criteria prior therapy
T3,T4
M1
Target sample size 189

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Okamoto
Organization Tokyo Women's Medical University
Division name Department of Breast and Endocrine Surgery
Zip code
Address Kawadacho 8-1, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email okamoto.takahiro@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Hirano
Organization Tokyo Women's Medical University, Medical Center East
Division name Department of Breast Surgery
Zip code
Address Nishi-ogu 2-1-10, Arakawa-ku, Tokyo
TEL 03-3810-1111
Homepage URL
Email ahirasu@dnh.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
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
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
2016 Year 08 Month 30 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
2016 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 08 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
2016 Year 08 Month 01 Day
Last modified on
2016 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026489

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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