UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056630 |
|---|---|
| Receipt number | R000064722 |
| Scientific Title | A Retrospective Multi-center Cohort Study Investigating Safety of Sentinel Lymph Node Biopsy in Clinical T3-4c Breast Cancer |
| Date of disclosure of the study information | 2025/01/05 |
| Last modified on | 2025/01/05 09:40:58 |
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Basic information
Public title
A Retrospective Multi-center Cohort Study Investigating Safety of Sentinel Lymph Node Biopsy in Clinical T3-4c Breast Cancer
Acronym
A Retrospective Multi-center Cohort Study Investigating Safety of Sentinel Lymph Node Biopsy in Clinical T3-4c Breast Cancer
Scientific Title
A Retrospective Multi-center Cohort Study Investigating Safety of Sentinel Lymph Node Biopsy in Clinical T3-4c Breast Cancer
Scientific Title:Acronym
A Retrospective Multi-center Cohort Study Investigating Safety of Sentinel Lymph Node Biopsy in Clinical T3-4c Breast Cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Explore the safety of axillary staging with sentinel lymph nodes in cT3 and T4.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence free survival
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
Male and Female
Key inclusion criteria
cases of cT3-4a-cN0M0 breast cancer who underwent radical surgery at the institution between January 1, 2006 and December 31, 2016
Key exclusion criteria
1. cases in which axillary surgery (SNB or Ax) was not performed
2. cases of positive sentinel node metastasis for which an Ax was omitted
3. cases in which the sentinel node could not be identified and axillary lymph node sampling was performed
4. cases with a history of breast cancer before the diagnosis of cT3-4a-cN0 breast cancer (heterochronic breast cancer), excluding noninvasive ductal carcinoma of the breast
5. cases in which contralateral breast cancer was diagnosed at the same time as the diagnosis of cT3-4a-cN0 breast cancer (contralateral contralateral breast cancer), excluding noninvasive ductal carcinoma of the breast
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Kuba |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
8528501
Address
1-7-1 Sakamoto-Machi, Nagasaki 852-8501, Japan
TEL
0958197316
skuba@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Kuba |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
8528501
Address
1-7-1 Sakamoto-Machi, Nagasaki 852-8501, Japan
TEL
0958197316
Homepage URL
sayaka20041123@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 05 | 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
930
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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2025 | Year | 01 | Month | 05 | Day |
Last modified on
| 2025 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064722
