UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011782 |
|---|---|
| Receipt number | R000013776 |
| Scientific Title | Observational study of axilla treatment for breast cancer patients with micrometastases or 1 to 3-positive macrometastases in sentinel lymph nodes |
| Date of disclosure of the study information | 2013/09/18 |
| Last modified on | 2013/09/17 15:08:14 |
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Basic information
Public title
Observational study of axilla treatment for breast cancer patients with micrometastases or 1 to 3-positive macrometastases in sentinel lymph nodes
Acronym
Observational study of axilla treatment for breast cancer patients with positive sentinel lymph nodes
Scientific Title
Observational study of axilla treatment for breast cancer patients with micrometastases or 1 to 3-positive macrometastases in sentinel lymph nodes
Scientific Title:Acronym
Observational study of axilla treatment for breast cancer patients with positive sentinel lymph nodes
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore axillary lymph node dissection, breast cancer patients with pN1mi(sn) and pN1(sn) will be observed prospectively irrespective of axillary treatment.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
regional recurrence rate in patients treated with no axillary lymph node dissection
Key secondary outcomes
5-year overall survival of patients after primary therapy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
cases with T1-3N0-1M0 breast cancer (UICC 8th ver.)
Invasive cancer proven by breast tissue biopsy
pN1mi(sn) or pN1(sn) diagnosed by sentinel node biopsy
treatment planned from January 2012
eligible for any case with relapse or no relapse
Key exclusion criteria
cases with T4 or distant metastasis
cases with pN0(sn) or pN0(i+)(sn)
cases with more than 3 of micrometastases or macromestastases in sentinel lymph nodes
cases with pregnancy or breast-feeding
cases with bilateral breast cancer
cases with past history of any kind of invasive cancer treated within 5 years
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Imoto |
Organization
Kyorin University Hospital
Division name
Department of Breast Surgery
Zip code
Address
6-20-2 Shinkawa Mitaka Tokyo 181-8611, JAPAN
TEL
0422-47-5511
imoto@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Yana |
Organization
Japanese Society for Sentinel Node Navigation Surgery
Division name
office
Zip code
Address
35 Shinanomachi Shinjuku Tokyo 160-8582
TEL
03-3353-6440
Homepage URL
yanas@z7.keio.jp
Sponsor or person
Institute
Japanese Society for Sentinel Node Navigation Surgery
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Sentinel Node Navigation Surgery
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
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
杏林大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 18 | 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
| 2013 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
If regional recurrence rate in cases with no axillary lymph node dissection is estimated at 5%, 240 patients will be needed to give a 80% power to reject null hypothesis that the recurrence rate is 10% with one-sided type I error rate of 2.5%. After considering lost to follow-up or ineligible case, total of 250 is set to the sample size. In this study, patients with axillary lymph node dissection will also be registered. Propensity score will be calculated using clinico-pathological factors and events of recurrence. Finally, prognosis will be analyzed in cases of the 2 groups matched with propensity score.
Management information
Registered date
| 2013 | Year | 09 | Month | 17 | Day |
Last modified on
| 2013 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013776
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
