UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016888 |
|---|---|
| Receipt number | R000019603 |
| Scientific Title | Retrospective analysis of prognosis in sentinel node-positive breast cancer patients who received no axillary lymph node dissection |
| Date of disclosure of the study information | 2015/03/30 |
| Last modified on | 2015/03/24 10:04:23 |
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Basic information
Public title
Retrospective analysis of prognosis in sentinel node-positive breast cancer patients who received no axillary lymph node dissection
Acronym
Prognosis in sentinel node-positive breast cancer patients who received no axillary lymph node dissection
Scientific Title
Retrospective analysis of prognosis in sentinel node-positive breast cancer patients who received no axillary lymph node dissection
Scientific Title:Acronym
Prognosis in sentinel node-positive breast cancer patients who received no axillary lymph node dissection
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate no axillary lymph node dissection in breast cancer patients with pN1mi(sn) or pN1(sn), prognosis in this cohort is analyzed retrospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
regional node recurrence and overall survival rate after 5 years of sentinel node biopsy
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Surgical treatment between 2008 and 2011
2) T1-3 N0 M0
3) Invasive carcinoma proven by histological examination
4) 1-3 micrometastases and/or macrometastases in sentinel nodes
5) No axillary lymph node dissection
Key exclusion criteria
1) Non-invasive carcinoma of the breast
2) T4N1 or more advanced, or M1
3) Sentinel nodes with no metastases or isolated tumor cells
4) Synchronous or metachronous bilateral breast cancer
5) Cases with pregnancy or lactating breast
6) Cases with drug therapy or radiation therapy before sentinel node biopsy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Imoto |
Organization
School of Medicine, Kyorin University
Division name
Department of Breast Surgery
Zip code
Address
2-21-21 Shinkawa Mitaka Tokyo Japan
TEL
0422-47-5511
imoto@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Takano |
Organization
School of Medicine, Kyorin University
Division name
Department of Breast Surgery
Zip code
Address
6-20-2 Shinkawa Mmitaka Tokyo 181-8611, JAPAN
TEL
0422-47-6273
Homepage URL
k-takano@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Group study at the Japanese Breast Cancer Society in 2014
Institute
Department
Personal name
Funding Source
Organization
Japanese Breast Cancer Society
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | 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
retrospective cohort study
Management information
Registered date
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2015 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019603
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| Registered date | File name |
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