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Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy (CRYOSE01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576106
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Tracking Information
First Submitted Date  ICMJE October 12, 2015
First Posted Date  ICMJE October 15, 2015
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
The rate of success of cryoablation procedure [ Time Frame: 45 days after cryoablation ]
percentage of viable cells in the piece of lumpectomy
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
To evaluate the rate of success of cryoablation procedure [ Time Frame: 45 days after cryoablation ]
percentage of viable cells in the piece of lumpectomy
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
Official Title  ICMJE Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
Brief Summary

The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.

The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.

On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Ductal, Breast
  • Menopausal
Intervention  ICMJE Device: Cryoablation
Other Name: Cryotherapy
Study Arms  ICMJE Experimental: Cryoablation
Cryoablation of the tumor followed by a lumpectomy as practiced in standard care
Intervention: Device: Cryoablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2020)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2015)
20
Actual Study Completion Date  ICMJE January 2020
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
  • Menopausal women with age > 55 years
  • Tumor size <= 15 mm by ultrasonography
  • Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis & Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
  • Good lesion boundary with ultrasonography and MRI
  • Minimal distance of 5 mm between the skin and the tumor
  • Performance Status 0-1
  • Ability to understand and willingness to sign a written informed consent document
  • Covered by a medical insurance
  • Signed informed consent

Exclusion Criteria:

  • Invasive lobular carcinoma
  • Tumor with retro-nipple location
  • Extended microcalcifications (> 15 mm) with mammography
  • Xylocaine allergy
  • Patient deprived of freedom
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02576106
Other Study ID Numbers  ICMJE ET15-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Centre Leon Berard
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Leon Berard
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frank Pilleul, MD-PhD Centre Leon Berard
PRS Account Centre Leon Berard
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP