UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060220 |
|---|---|
| Receipt number | R000068625 |
| Scientific Title | Multicentric retrospective observational study for the significance of repeat sentinel lymphnode biopsy in patients with ipsilateral breast tumor recurrence (B-STRO) |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2025/12/28 10:36:06 |
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Basic information
Public title
Multicentric retrospective observational study for the significance of repeat sentinel lymphnode biopsy in patients with ipsilateral breast tumor recurrence (B-STRO)
Acronym
MOTIVATION - Repeat SLNB
Scientific Title
Multicentric retrospective observational study for the significance of repeat sentinel lymphnode biopsy in patients with ipsilateral breast tumor recurrence (B-STRO)
Scientific Title:Acronym
MOTIVATION - Repeat SLNB
Region
| Japan |
Condition
Condition
Ipsilateral breast tumor recurrence: IBTR
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the importance of performing an axillary sentinel lymph node biopsy at the same time as breast surgery for IBTR.
Basic objectives2
Others
Basic objectives -Others
The significance includes local control, improved prognosis, lymphatic basin mapping, and the feasibility of sentinel lymph node metastasis diagnosis, which will be clarified.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Endpoint: Distant Disease-Free Survival (DDFS)
Key secondary outcomes
Secondary Endpoints
a) Relapse-Free Survival (RFS),
b) Local Control Rate
c) Lymphatic mapping success rate,
d) The frequency of aberrant lymphatic flow outside the ipsilateral axilla,
e) Sentinel lymph node detection rate,
f) Sentinel lymph node metastasis rate,
g) Adverse events (ipsilateral upper limb edema, upper limb motor paralysis, etc.)
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
1) Patients aged 20 years or older who did not opt out
2) Patients diagnosed with histopathologically confirmed breast cancer
3) Patients with postoperative recurrence in the preserved breast
Key exclusion criteria
1) Patients with obvious distant metastases at registration
2) Patients with concurrent active multiple cancers
3) Patients deemed unsuitable as study subjects by the principal investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Sapporo Medical University
Division name
Department Surgery, division of Breast Surgery
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Japan
TEL
+81-11-611-2111
simahiro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Sapporo Medical University
Division name
Department Surgery, division of Breast Surgery
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Japan
TEL
+81-11-611-2111
Homepage URL
https://web.sapmed.ac.jp/byoin/rinshokenkyu/koukai/
simahiro@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Clinical Trial Center, Sapporo Medical University
Address
S1, W16, Chuo-ku, Sapporo, Japan
Tel
+81-11-611-2111
simahiro@sapmed.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
| 2026 | 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
70
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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will analyze the status of initial surgery for breast cancer and the treatment for IBTR along with its peri-operative conditions.
We will investigate the current status of re-sentinel lymph node biopsy.
Management information
Registered date
| 2025 | Year | 12 | Month | 28 | Day |
Last modified on
| 2025 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068625
