UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046510 |
|---|---|
| Receipt number | R000053063 |
| Scientific Title | The Observational Study of Sentinel Lymph Node Biopsy for Patients with Lymph Node-Positive Breast Cancer Responding to Preoperative Chemotherapy in Clinical Practice |
| Date of disclosure of the study information | 2021/12/28 |
| Last modified on | 2022/01/06 09:38:56 |
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Basic information
Public title
The Observational Study of Sentinel Lymph Node Biopsy for Patients with Lymph Node-Positive Breast Cancer Responding to Preoperative Chemotherapy in Clinical Practice
Acronym
The Observational Study of Sentinel Lymph Node Biopsy for Patients with Lymph Node-Positive Breast Cancer Responding to Preoperative Chemotherapy in Clinical Practice
Scientific Title
The Observational Study of Sentinel Lymph Node Biopsy for Patients with Lymph Node-Positive Breast Cancer Responding to Preoperative Chemotherapy in Clinical Practice
Scientific Title:Acronym
The Observational Study of Sentinel Lymph Node Biopsy for Patients with Lymph Node-Positive Breast Cancer Responding to Preoperative Chemotherapy in Clinical Practice
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the observation study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of recurrence for lymph nodes after two years
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
No more than 4 lymph node metastases
Key exclusion criteria
Cases in which preoperative chemotherapy is not indicated
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Rikiya |
| Middle name | |
| Last name | Nakamura |
Organization
Chiba Cancer Center
Division name
The division of breast surgery
Zip code
2608717
Address
666-2 nitona-chou chuouku-chiba
TEL
043-264-5431
rnakamura@chiba-cc.jp
Public contact
Name of contact person
| 1st name | Rikiya |
| Middle name | |
| Last name | Nakamura |
Organization
Chiba Cancer Center
Division name
The division of breast surgery
Zip code
2608717
Address
666-2 nitona chuouku chiba
TEL
043-264-5431
Homepage URL
rnakamura@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center1,the division of breast surgery
Institute
Department
Personal name
Funding Source
Organization
Chiba Cancer Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Cancer Center
Address
666-2 nitona chuouku chiba
Tel
043-264-5431
rnakamura@chiba-cc.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
| 2021 | Year | 12 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053063
