UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049737 |
|---|---|
| Receipt number | R000056651 |
| Scientific Title | A retrospective cohort study of axilla management in ipsilateral breast tumor recurrence after partial mastectomy with sentinel node biopsy |
| Date of disclosure of the study information | 2022/12/20 |
| Last modified on | 2022/12/09 11:34:36 |
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Basic information
Public title
A retrospective cohort study of axilla management in ipsilateral breast tumor recurrence after partial mastectomy with sentinel node biopsy
Acronym
Axillary management in cases of IBTR
Scientific Title
A retrospective cohort study of axilla management in ipsilateral breast tumor recurrence after partial mastectomy with sentinel node biopsy
Scientific Title:Acronym
Axillary management in cases of IBTR
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine optimization of axillary treatment in cases of IBTR, repeat SNB is evaluated retrospectively.
Basic objectives2
Others
Basic objectives -Others
Success rate of repeat SNB
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validation of repeat SNB
Key secondary outcomes
Outcome in cases of IBTR
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
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
All criteria should be required.
1) Cases of primary breast cancer with clinically Tis to T4N0M0 at UICC ver.8 performed with SNB
2) Cases of primary breast cancer treated with no axillary lymph node dissection
3) Cases of IBTR diagnosed from January 2010 to August 2022
Key exclusion criteria
1) Cases of primary breast cancer with clinically positive node or distant metastasis.
2) Cases of synchronous or metachronous bilateral breast cancer before IBTR
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Imoto |
Organization
School of Medicine Kyorin University
Division name
Department of Breast Surgery
Zip code
181-8611
Address
6-20-2 Shinkawa Mitaka
TEL
0422-47-5511
imoto@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Yana |
Organization
Japanese Society for Sentinel Node Navigation Surgery
Division name
Office
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-Ku
TEL
03-3353-1211
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
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Society for Sentinel Node Navigation Surgery
Address
35 Shinanomachi Shinjuku-Ku
Tel
03-3353-1211
yanas@z7.keio.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
| 2022 | Year | 12 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No additional information
Management information
Registered date
| 2022 | Year | 12 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056651
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