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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031222
Receipt No. R000035655
Scientific Title Safety and effectiveness of non resection ultrasound guided cryotherapy for localized early breast cancer
Date of disclosure of the study information 2018/02/25
Last modified on 2019/03/22

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Basic information
Public title Safety and effectiveness of non resection ultrasound guided cryotherapy for localized early breast cancer
Acronym Safety and effectiveness of non resection ultrasound guided cryotherapy for localized early breast cancer
Scientific Title Safety and effectiveness of non resection ultrasound guided cryotherapy for localized early breast cancer
Scientific Title:Acronym Safety and effectiveness of non resection ultrasound guided cryotherapy for localized early breast cancer
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety and effectiveness of non resection ultrasound guided cryotherapy for localized early breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Vacuum-assisted biopsy is performed to check whether viable cancer tissue remains 1 month after non-resected ultrasound guided cryotherapy.
Key secondary outcomes

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 IceSense3(IceCureCo.,Israel)
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Female
Key inclusion criteria 1:ECOG Performance Status(PS)0~1
2:Women20to85years old
3:For the first time, it is diagnosed as invasive breast cancer by histologic examination
4:Subtype diagnosis results Hormone receptor positive, HER2 protein expression negative(no DNA amplification), Ki-67<=20%
5:Breast cancer lesions with primary lesions of MMG, US, CT, MRI and lesion spreads of1.5cm or less are the primary lesions.
6:It is diagnosed that there is a high possibility that the sentinel lymph node(SLN)is negative in the preoperative image diagnosis.
7:Sentinel lymph node biopsy and radiation therapy after cryotherapy are possible.
8:There is no systemic infectious disease with poor control9:After sufficient explanation, patient informed consent(IC) was obtained in writing.
Key exclusion criteria 1:If there is an offer to study non-participation from patients, stop this and exclude it from the study.
2:Patient with distant metastasis.
3:Even if we meet the indication criteria 1,2,3 it is diagnosed as invasive lobular carcinoma, invasive micro papillary carcinoma.
4:MMG, US, CT, MRI admitted lymph duct lesions and daughter nodules around.
5:Cases in proximity of frostbite dangerous skin and chest muscle are not indicated.
6:Other things that the doctor in charge considers inappropriate.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Koichiro
Middle name
Last name Tsugawa
Organization St.Marianna University School of Medicine
Division name Breast Endocrine Surgery
Zip code 216-8511
Address 2-16-1 Sugao Miyamae-Ku KawasakiCity Kanagawa
TEL 81-44-977-8111
Email koitsuga@marianna-u.ac.jp

Public contact
Name of contact person
1st name Hisanori
Middle name
Last name Kawamoto
Organization St.Marianna University School of Medicine
Division name Breast Endocrine Surgery
Zip code 216-8511
Address 2-16-1 Sugao Miyamae-Ku KawasakiCity Kanagawa
TEL 81-44-977-8111
Homepage URL
Email h-kawamoto@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization St.Marianna University School of Medicine Breast Endocrine Surgery
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 St.Marianna University School of Medicine
Address 2-16-1 Sugao Miyamae-Ku KawasakiCity Kanagawa
Tel 81-44-977-8111
Email k-sienbu.mail@marianna-u.ac.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
2018 Year 02 Month 25 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 8
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 No longer recruiting
Date of protocol fixation
2018 Year 02 Month 07 Day
Date of IRB
2017 Year 07 Month 07 Day
Anticipated trial start date
2018 Year 04 Month 26 Day
Last follow-up date
2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 03 Month 29 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 09 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035655

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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