UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020561 |
|---|---|
| Receipt number | R000023514 |
| Scientific Title | No axillary dissection for breast cancer patients with metastatic sentinel lymph node |
| Date of disclosure of the study information | 2016/01/14 |
| Last modified on | 2016/01/20 13:07:28 |
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Basic information
Public title
No axillary dissection for breast cancer patients with metastatic sentinel lymph node
Acronym
near me
Scientific Title
No axillary dissection for breast cancer patients with metastatic sentinel lymph node
Scientific Title:Acronym
near me
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of no axillary dissection among breast cancer with limited sentinel lymph node metastasis planning to undergo breast-conserving surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
axillary local recurrence rate
Key secondary outcomes
disease-free survival,over all survival
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
T1-2N0M0 breast cancer treated with breast-conserving surgery and systematic therapy
Key exclusion criteria
Three and more sentinel lymph node metastases
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
Address
2-11-1 Kaga,Itabashi,Tokyo
TEL
03-3964-1231
miosaiga@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
Address
2-11-1 Kaga,Itabashi,Tokyo
TEL
03-3964-1231
Homepage URL
miosaiga@med.teikyo-u.ac.jp
Sponsor or person
Institute
Department of Surgery,Teikyo University School of Medicine
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
Address
Tel
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
| 2016 | Year | 01 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective study.
Patiets who meet the criteria of this study are enrolled from November 2015 to March 2020.
Management information
Registered date
| 2016 | Year | 01 | Month | 14 | Day |
Last modified on
| 2016 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023514
| Research Plan | |
|---|---|
| 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 |
