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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030510
Receipt No. R000034829
Scientific Title Feasibility of sentinel lymph node biopsy for acquired clinical node-negative breast cancer after neoadjuvant therapy in node-positive breast cancer, multi-centric, single arm, phase II, confirmatory study
Date of disclosure of the study information 2017/12/25
Last modified on 2019/09/19

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Basic information
Public title Feasibility of sentinel lymph node biopsy for acquired clinical node-negative breast cancer after neoadjuvant therapy in node-positive breast cancer, multi-centric, single arm, phase II, confirmatory study
Acronym Sentinel lymph node biopsy after neoadjuvant therapy in node-positive breast cancer
Scientific Title Feasibility of sentinel lymph node biopsy for acquired clinical node-negative breast cancer after neoadjuvant therapy in node-positive breast cancer, multi-centric, single arm, phase II, confirmatory study
Scientific Title:Acronym Sentinel lymph node biopsy after neoadjuvant therapy in node-positive breast cancer
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of sentinel lymph node biopsy for acquired clinical node-negative breast cancer after neoadjuvant therapy in node-positive breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 3-year axillary lymph node relapse free survival
Key secondary outcomes Diagnostic potential of SNB
3-year disease-free and overall survival
Relation between relapse site and clinicopathological factor
Rate of arm lymphedema

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 Treatment
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 Female
Key inclusion criteria Aquired clinical node negative breast cancer after neoadjuvant therapy
Key exclusion criteria Inoperable case
Inflammatory breast cancer
Progressive disease after neoadjuvant therapy
Target sample size 62

Research contact person
Name of lead principal investigator
1st name Yoshinari
Middle name
Last name Ogawa
Organization Osaka City General Hospital
Division name Department of Breast Surgical Oncology
Zip code 534-0021
Address 2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL 06-6929-1221
Email p8581189@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Yoshinari
Middle name
Last name Ogawa
Organization Osaka City General Hospital
Division name Department of Breast Surgical Oncology
Zip code 534-0021
Address 2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL 06-6929-1221
Homepage URL
Email p8581189@msic.med.osaka-cu.ac.jp

Sponsor
Institute Osaka City General Hospital
Institute
Department

Funding Source
Organization Osaka City General Hospital
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 IRB, Osaka City General Hospital
Address 2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
Tel 06-6929-3269
Email xc0017@osakacity-hp.or.jp

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 大阪市立総合医療センター(大阪府)、大阪市立大学医学部付属病院(大阪府)、住友病院(大阪府)、石切生喜病院(大阪府)、市立柏原病院(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 12 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 01 Day
Date of IRB
2018 Year 01 Month 09 Day
Anticipated trial start date
2018 Year 02 Month 07 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 21 Day
Last modified on
2019 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034829

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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