UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005321 |
|---|---|
| Receipt number | 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 16:03:23 |
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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
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
Sponsor or person
Institute
Japanese Study Group of the OSNA assay
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005635
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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