UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027267 |
|---|---|
| Receipt number | R000031238 |
| Scientific Title | Efficacy and safety of the breast biopsy marker (UltraClip) insertion in patients with breast cancer who undergo neoadjuvant chemotherapy |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2022/11/15 13:20:52 |
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Basic information
Public title
Efficacy and safety of the breast biopsy marker (UltraClip) insertion in patients with breast cancer who undergo neoadjuvant chemotherapy
Acronym
Efficacy and safety of UltraClip in cases of neoadjuvant chemotherapy
Scientific Title
Efficacy and safety of the breast biopsy marker (UltraClip) insertion in patients with breast cancer who undergo neoadjuvant chemotherapy
Scientific Title:Acronym
Efficacy and safety of UltraClip in cases of neoadjuvant chemotherapy
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
When USMMT is performed , we insert UltraClip in tumor which suspects breast cancer that may discussed with neoadjuvant chemotherapy.
The aim are to find the UltraClip and to evaluate the therapy effect of the UltraClip insertion part after neoadjuvant chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
False-negative rate in the cCR group
Key secondary outcomes
Stump negative rate
Safety of UltraClip
The marker insertion rate in the operation group and non cCR group
The marker insertion rate in residual tumor in the Non pCR group
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention is only once at the time of USMMT.
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
The patients are diagnosed the breast cancer by physical examination and image.
The patient was provided in a document about the participation in this study from a subject
Key exclusion criteria
The patients have a low probability of neoadjvant chemotherapy.
The patients is likely to the benign tumor.
The patients are judged that the medical attendant was inadequate for this trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Kataoka |
Organization
Aichi Cancer Center Hospital
Division name
Department of Breast oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya city, Aichi, Japan
TEL
052-762-6111
a-kataoka@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Kataoka |
Organization
Aichi Cancer Center Hospital
Division name
Department of Breast oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya city, Aichi, Japan
TEL
052-762-6111
Homepage URL
a-kataoka@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Department of Breast oncology
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
Department of Breast oncology
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
Aichi Cancer Center Hospital Institutional review board
Address
1-1 Kanokoden, Chikusa-ku, Nagoya city, Aichi, Japan
Tel
0527626111
y_hasegawa @aichi-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
| 2017 | Year | 05 | 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
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
in the process of submitting a paper
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 08 | Day |
Last modified on
| 2022 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031238
