- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01856036
Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
February 3, 2017 updated by: Saint John's Cancer Institute
CHUM-CRYOABLATION: Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
This protocol will study the impact of cryoablation on immune response in patients diagnosed with invasive breast cancers smaller than 1.5 cm.
It will profile the immune response to cryoablation of invasive breast cancers.
The intra-tumoral and systemic immune response to cryoablation will be determined and compared to pre-ablated breast cancer specimens and historical control specimens.
Study Overview
Detailed Description
Patients with small breast cancers will undergo cryoablation of their breast cancer.
Approximately six weeks after cryoablation, definitive breast surgery will be performed.
Blood will be drawn for research before cryoablation and surgery and at regular follow-up visits.
Blood and tissue samples will be used to determine immune responses.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Monica, California, United States, 90404
- Saint John's Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with an invasive breast cancer 1.5 cm or less
- The breast cancer must be of ductal histology, unifocal, estrogen receptor positive and her2/neu negative.
- The tumor must be visible by ultrasound and the subject must not have had prior surgical resection of the primary lesion.
- A clip marking the breast cancer must have been placed at the time of initial diagnosis or will be placed prior to cryotherapy.
- The breast cancer must be amenable to cryoablation (visible by ultrasound and more than 2 mm from skin or chest wall).
- Subjects with metastatic disease at diagnosis who elect to have their primary tumor excised are eligible for enrollment.
- For subjects with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion with not contact or jeopardize the implant.
- Subjects must be able to provide consent.
Exclusion Criteria:
- Subjects with breast cancers of lobular histology, with lymph vascular invasion or extensive intraductal component will be excluded.
- Subjects with multi-centric or multi-focal breast cancers
- Subjects with breast cancers that have invaded skin or have significant skin tethering (assessed clinically).
- Subjects receiving chemotherapy within one year or undergoing neoadjuvant chemotherapy are excluded.
- Subjects with metastatic disease at diagnosis will be excluded unless they elect definitive surgical therapy for their primary lesion.
- Subjects with breast cancers not amenable to cryoablation (lesions not visible by ultrasound, against the chest wall or within 2 mm of skin) will be excluded.
- Subjects diagnosed with another malignancy in the preceding 5 years will be excluded.
- Subjects diagnosed with simultaneous bilateral breast cancer.
- Subjects receiving immunosuppressive therapy within 6 months including oral steroids will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryoablation
Cryoablation of breast cancer will be performed using a freeze-thaw technique and an IceCure probe.
Cryoablation cycles will be determined by IceCure software programmed by the treating surgeon.
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Cryoablation of breast cancer will be performed using a freeze-thaw technique and an IceCure probe.
Cryoablation cycles will be determined by IceCure software programmed by the treating surgeon.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers
Time Frame: 12 Months
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12 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the intra-tumoral and systemic response between non-ablated and ablated breast cancer and pre-ablated and post ablated serum
Time Frame: 24 Months
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24 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
April 18, 2013
First Submitted That Met QC Criteria
May 14, 2013
First Posted (Estimate)
May 17, 2013
Study Record Updates
Last Update Posted (Estimate)
February 7, 2017
Last Update Submitted That Met QC Criteria
February 3, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUM-CRYOABLATION
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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