UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024997 |
|---|---|
| Receipt number | R000028754 |
| Scientific Title | a feasibility study of partial resection of non-palpable breast cancer with calcification by Ultra breast marker. |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2018/11/28 10:10:13 |
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Basic information
Public title
a feasibility study of partial resection of non-palpable breast cancer with calcification by Ultra breast marker.
Acronym
Ultra breast marker feasibility study
Scientific Title
a feasibility study of partial resection of non-palpable breast cancer with calcification by Ultra breast marker.
Scientific Title:Acronym
Ultra breast marker feasibility study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to verify the safety and accuracy of breast conserving surgery for non-palpable calcification breast cancer with Ultra breast marker
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
feasibility: to insert breast marker safety and accurately into the target site when inserting the Ultra breast marker
Key secondary outcomes
margin positive rate, boost radiation, additional resection, operation time, allergy
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
| Device,equipment |
Interventions/Control_1
Patients receive Ultra breast marker at the time of stereo-mammotome biopsy against non-palpable calcified lesions suspected of being breast cancer
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
Female
Key inclusion criteria
1) The patient who undergoes ST-MMT in the Aichi Cancer Center Hospital for non-palpable calcified lesions(category 3 or more) suspected of breast cancer
2) The calcified lesions can't be identified by US.
3) ECOG performance status PS0
4) Patient age is 18 years or older
5) Platelet : 10000 and more
PT-INR 1.5 or less
6)informed consent
7) Without platelet aggregation inhibitor, Anticoagulant
8) Patients have to receive detailed US
Key exclusion criteria
1) The lesion can be identified by the US.
2) Total Mastectomy is planned.
3) Informed consent is not obtained.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Madoka Iwase |
Organization
Aichi Cancer Center Hospital
Division name
Breast Oncology
Zip code
Address
1-1 kanokoden chikusa nagoya
TEL
0527626111
miwase@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Madoka Iwase |
Organization
Aichi Cancer Center Hospital
Division name
Breast Oncology
Zip code
Address
1-1 kanokoden chikusa nagoya
TEL
0527626111
Homepage URL
miwase@aichi-cc.jp
Sponsor or person
Institute
Aichi cancer center
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 | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 25 | Day |
Last modified on
| 2018 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028754
