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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000027267
Receipt No. 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 2017/05/08

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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
Middle name
Last name Ayumi Kataoka
Organization Aichi Cancer Center Hospital
Division name Department of Breast oncology
Zip code
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
Middle name
Last name Ayumi Kataoka
Organization Aichi Cancer Center Hospital
Division name Department of Breast oncology
Zip code
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
Address
Tel
Email

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
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
Date of protocol fixation
2016 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
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
2017 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031238

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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