UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048884 |
|---|---|
| Receipt number | R000055701 |
| Scientific Title | Axillary evaluation with targeted axillary dissection using ultrasound visible clips after neoadjuvant chemotherapy for patients with node-positive breast cancer |
| Date of disclosure of the study information | 2022/09/08 |
| Last modified on | 2022/09/08 13:31:08 |
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Basic information
Public title
Axillary evaluation with targeted axillary dissection using ultrasound visible clips after neoadjuvant chemotherapy for patients with node-positive breast cancer
Acronym
Axillary evaluation with targeted axillary dissection
Scientific Title
Axillary evaluation with targeted axillary dissection using ultrasound visible clips after neoadjuvant chemotherapy for patients with node-positive breast cancer
Scientific Title:Acronym
Axillary evaluation with targeted axillary dissection
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility and accuracy of targeted axillary dissection using an ultrasound visible clip for the axillary staging of patients with node-positive breast cancer treated with NAC, with the secondary aim of assessing the US visibility of the clip and localization technique of TAD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
False negative rate of the targeted axillary dissection is assessed
Key secondary outcomes
Ultrasound identification rate and success removal rate of the clipped node using several localization technique such as fluorescence technique, wire localization, dye injection method, or combination of these techniques under US guidance are assessed
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After a clip is placed in the biopsy-proven node under US guidance, neoadujuvant chematherapy is performed. At the time of surgery, clipped node is removed followed by sentinel lymph node biopsy.
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
patients with clinical T1-3, N1,2, M0 breast cancer undergoing NAC followed by surgery.
Key exclusion criteria
Patients with internal mammary lymph node metastasis, prior axillary surgery, or pregnancy
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Fukuma |
Organization
Kameda Medical Center
Division name
Breast Center
Zip code
290-8602
Address
929, Higashi cho, Kamogawa, Chiba
TEL
0470-92-2211
fukuma.eisuke@kameda.jp
Public contact
Name of contact person
| 1st name | Hiroe |
| Middle name | |
| Last name | Sugane |
Organization
Kameda Medical Center
Division name
Breast Center
Zip code
290-8602
Address
929, Higashi cho, Kamogawa, Chiba
TEL
0470-92-2211
Homepage URL
sugane.hiroe@kameda.jp
Sponsor or person
Institute
Breast Center, Kameda medical center
Institute
Department
Personal name
Funding Source
Organization
Breast Center, Kameda medical center
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
Kameda Medical Center
Address
929 Higashi cho, Kamogawa, Chiba
Tel
0470-92-2211
clinical_research@kameda.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
亀田総合病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 08 | 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
26
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055701
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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