UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031222 |
|---|---|
| Receipt number | 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 | 2021/02/22 21:22:13 |
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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
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
h-kawamoto@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
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
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
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000035655
Publication of results
Unpublished
Result
URL related to results and publications
http://www.marianna-u.ac.jp/breast/02_sinryo_annnai/cryotherapy.html
Number of participants that the trial has enrolled
8
Results
Pathological analysis of VAB tissue revealed complete elimination of cancer cells in all seven cases treated by cryoablation.
Results date posted
| 2021 | Year | 02 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No. Age HT ER(%) PgR(%) Ki-67(%) size at baseline location SLN
1 66 IDC 99 90 1-9 10.59 Upper outer left 0/3
2 54 IDC 80 30 10-20 6.80 Upper inner right 0/1
3 67 IDC 99 0 1-9 12.20 Upper outer right 0/1
4 70 IDC 99 20 10-20 14.49 Upper inner left 0/1
5 53 MCN 99 90 10-20 8.50 Upper outer right 0/1
6 55 IDC 99 30 1-9 8.90 Upper mid left 0/1
7 58 IDC 90 100 10-20 13.00 Lower outer left 0/2
8 59 IDC 90 90 10-20 14.00 1/1
(no.8:Excluded duo to SLN positivity)
Participant flow
This study was conducted at St. Marianna University Breast and Imaging Center, Kawasaki City, Japan. The primary endpoint was complete tumor ablation after cryoablation, defined as no remaining invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) detected by pathological examination of the target lesion site by vacuum-assisted biopsy (VAB). Secondary endpoints were skin changes (with or without freezing injury) and other adverse events after cryoablation. All patients gave written informed consent prior to treatment. Primary registration criteria were Eastern Cooperative Oncology Group Performance Status of 0 or 1, age 20 to 85 years, first-onset IDC of the breast, hormone receptor-positive status, HER2 protein expression-negative status (i.e., without DNA amplification), Ki-67 positivity less than 20%, a single primary lesion as revealed by mammography (MG), ultrasonography (US), computerized tomography (CT), and (or) magnetic resonance imaging (MRI), lesion spread of 1.5 cm or less, possible sentinel lymph node (SLN) negativity according to preoperative imaging, and amenable to radiation therapy after SLN biopsy and cryoablation (Fig. 1). The secondary registration criterion was negative SLN biopsy results. Exclusion criteria were invasive lobular carcinoma, invasive micropapillary carcinoma, intraductal lesions, daughter nodules found by MG, US, CT, and (or) MRI, and lesions close to the skin and pectoralis major muscle (conferring a high risk of freezing injury).
Adverse events
No skin freezing injury was observed in any case. In one case (no.3), skin redness was observed 1 week after cryoablation but disappeared in about 2 weeks after oral administration of antibiotics and anti-inflammatory analgesics. There were no symptoms such as pain in the area of freezing injury to the pectoralis major muscle. Regarding evaluation of good cosmetic outcomes using Moire topography, no distortion of streaks or deviation of nipple position was observed after cryoablation; therefore, the cosmetic outcome was considered as good.
Outcome measures
The 95% confidence interval for proportion of the collected tissue samples was examined for the presence of residual cancer cells by histopathology and was found to be 0.0%-41.0%.
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
| 2021 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035655
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