UMIN-CTR Clinical Trial

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
Email	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
Email	a-kataoka@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital Department of Breast oncology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031238