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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005321
Receipt No. R000005635
Scientific Title Clinical evaluation of molecular detection for sentinel lymph node examination in breast cancer patients
Date of disclosure of the study information 2011/04/01
Last modified on 2011/03/26

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Basic information
Public title Clinical evaluation of molecular detection for sentinel lymph node examination in breast cancer patients
Acronym Sentinel lymph node examination by means of the OSNA method
Scientific Title Clinical evaluation of molecular detection for sentinel lymph node examination in breast cancer patients
Scientific Title:Acronym Sentinel lymph node examination by means of the OSNA method
Region
Japan

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

Objectives
Narrative objectives1 Clinical evaluation of the OSNA method in detection of sentinel lymph node metastasis in breast cancer patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of sensitivity for detection of metastasis between the OSNA assay and conventional pathology
Key secondary outcomes

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
Other
Interventions/Control_1 Axillary dissection is omitted for patients who have no sentinel node metastasis examined by means of the OSNA assay.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Clinical N0 primary breast cancer patients who undergo sentinel lymph node biopsy
Key exclusion criteria Patients without their consent.
Patients who underwent primary systemic chemotherapy or primasy systemic hormonal therapy before sentinel lymph node biopsy.
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinzaburo Noguchi
Organization Osaka University Graduate School of Medicine
Division name Breast and Endocrine Surgery
Zip code
Address 2-2-E10, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3772
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Breast and Endocrine Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Japanese Study Group of the OSNA assay
Institute
Department

Funding Source
Organization Nakatani foundation
Organization
Division
Category of Funding Organization Non profit foundation
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 04 Month 01 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 No longer recruiting
Date of protocol fixation
2009 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 10 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 03 Month 26 Day
Last modified on
2011 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005635

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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