UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018316 |
|---|---|
| Receipt number | R000021199 |
| Scientific Title | Study on the omission of axillary lymph node dissection for breast cancer patients with metastases positive sentinel lymph node |
| Date of disclosure of the study information | 2015/07/15 |
| Last modified on | 2019/06/21 10:33:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the omission of axillary lymph node dissection for breast cancer patients with metastases positive sentinel lymph node
Acronym
Study on the omission of axillary lymph node dissection for sentinel node-positive breast cancer patients
Scientific Title
Study on the omission of axillary lymph node dissection for breast cancer patients with metastases positive sentinel lymph node
Scientific Title:Acronym
Study on the omission of axillary lymph node dissection for sentinel node-positive breast cancer patients
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the safety of no axillary lymph node dissection in sentinel node-positive breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate of axillary lymph node
Key secondary outcomes
5-year overall survival rate
5-year recurrent free survival rate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed breast cancer patients without distant metastasis
2) T1-2, NO
3) Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria
1) Patients who undergo breast surgery for ipsilateral breast tumor recurrence
2) Patients who undergo axillary lymph node dissection or sampling after sentinel lymph node biopsy
3) Patients who undergo neoadjuvant therapy
4)Patients who were judged inappropriate by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Motomura |
Organization
Osaka General Medical Center
Division name
Department of Breast Surgery
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
kenkyusien@gh.opho.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Motomura |
Organization
Osaka General Medical Center
Division name
Department of Breast Surgery
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
kenkyusien@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
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
Osaka General Medical Center
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
Tel
06-6692-1201
kenkyusien@gh.opho.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
大阪府立急性期・総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 15 | 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 | 05 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
No axillary lymph node dissection and recurrence rate
Management information
Registered date
| 2015 | Year | 07 | Month | 15 | Day |
Last modified on
| 2019 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021199
