UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047801 |
|---|---|
| Receipt number | R000054497 |
| Scientific Title | Study on standardizing the omission of axillary dissection for breast cancer with disappeared lymph node metastases after preoperative chemotherapy |
| Date of disclosure of the study information | 2022/05/20 |
| Last modified on | 2023/01/24 12:56:49 |
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Basic information
Public title
Study on standardizing the omission of axillary dissection for breast cancer with disappeared lymph node metastases after preoperative chemotherapy
Acronym
Study on standardizing the omission of axillary dissection for breast cancer with disappeared lymph node metastases after preoperative chemotherapy
Scientific Title
Study on standardizing the omission of axillary dissection for breast cancer with disappeared lymph node metastases after preoperative chemotherapy
Scientific Title:Acronym
Study on standardizing the omission of axillary dissection for breast cancer with disappeared lymph node metastases after preoperative chemotherapy
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine whether omitting axillary dissection increases the rate of local recurrence.
The subject is a case in which lymph node metastasis disappears after preoperative chemotherapy and sentinel lymph node is negative.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local recurrence rate
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Histologically diagnosed breast cancer (regardless of histological type)
2.Diagnosed as positive for axillary lymph node metastasis
3.At the time of diagnosis, hormone receptor is negative
4.Clips can be inserted into lymph nodes that are positive for metastasis
5.Within 3 lymph nodes suspected of metastasis
6.Preoperative chemotherapy is planned
7.Patients who have given written consent to participate in this study
Key exclusion criteria
1.Patients who cannot use the clips used in the research
2.Patients after breast implant insertion
3.Inflammatory breast cancer
4.Relapsed breast cancer
5.Pregnant patients
6.Patients who are infected or suspected of having an infectious disease
7.Patients who are judged to be ineligible at the discretion of the investigator
8.Sentinel lymph node cannot be identified
9.Clip lymph node cannot be identified
10.When the number of removed lymph nodes is less than the number determined to be metastatic lymph nodes before the start of treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Nakamura |
Organization
Showa University Hospital
Division name
Department of Breast Surgical Oncology
Zip code
142-8666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8000
showa-bc@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayuka |
| Middle name | |
| Last name | Nakayama |
Organization
Showa University Hospital
Division name
Department of Breast Surgical Oncology
Zip code
142-8666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8000
Homepage URL
osau0310@gmail.com
Sponsor or person
Institute
Department of Breast Surgical Oncology, Showa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Showa University
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
Tel
03-3784-8000
osau0310@gmail.com
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 | 05 | 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
| Delay expected |
Results Delay Reason
Case registration has been delayed due to measures against Coronavirus infection.
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After inserting a clip into the metastatic lymph node, preoperative chemotherapy and surgery are performed as scheduled.
After surgery, a breast ultrasound and a medical examination are performed at least once a year.
Management information
Registered date
| 2022 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054497
| 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 |
