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Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers

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: NCT01856036
Recruitment Status : Terminated (PI left institute and contacted IRB to close study.)
First Posted : May 17, 2013
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
John Wayne Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Cryoablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHUM-CRYOABLATION: Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
Actual Study Start Date : April 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.
Procedure: 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.




Primary Outcome Measures :
  1. Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers [ Time Frame: 12 Months ]
    1. Determine number (percentage via flow cytometry), phenotype and functionality of tumor infiltrating lymphocytes in ablated breast cancer
    2. Determine number (percentage via flow cytometry)and phenotype of APC in ablated breast cancer
    3. Characterize cytokine and chemokine expression (in IU) in ablated tissue and in pre-ablated and post-ablated serum over time
    4. Quantify T cell response (IUs of IL2 and IFN gamma, and T cell specific cells as measured by number of spots on an elispot assay) to tumor associated antigens using in vitro assays of T cell proliferation and function (cytokine release, elispot, peptide-MHC)
    5. Determine morphology and histology of regional lymph node after cryoablation


Secondary Outcome Measures :
  1. 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 ]
    1. Difference in intra-tumoral lymphocyte populations (percentage via flow cytometry) in ablated and non-ablated breast cancers
    2. Compare serum cytokine and chemokine expression (in IU) between patients undergoing or not undergoing tumor ablation
    3. Compare intra-tumoral lymphocyte populations (percentage via flow cytometry) in ablated tumor tissue with paraffin embedded specimens for tumors that are matched for age, tumor size and histology.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with an invasive breast cancer 1.5 cm or less
  2. The breast cancer must be of ductal histology, unifocal, estrogen receptor positive and her2/neu negative.
  3. The tumor must be visible by ultrasound and the subject must not have had prior surgical resection of the primary lesion.
  4. A clip marking the breast cancer must have been placed at the time of initial diagnosis or will be placed prior to cryotherapy.
  5. The breast cancer must be amenable to cryoablation (visible by ultrasound and more than 2 mm from skin or chest wall).
  6. Subjects with metastatic disease at diagnosis who elect to have their primary tumor excised are eligible for enrollment.
  7. 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.
  8. Subjects must be able to provide consent.

Exclusion Criteria:

  1. Subjects with breast cancers of lobular histology, with lymph vascular invasion or extensive intraductal component will be excluded.
  2. Subjects with multi-centric or multi-focal breast cancers
  3. Subjects with breast cancers that have invaded skin or have significant skin tethering (assessed clinically).
  4. Subjects receiving chemotherapy within one year or undergoing neoadjuvant chemotherapy are excluded.
  5. Subjects with metastatic disease at diagnosis will be excluded unless they elect definitive surgical therapy for their primary lesion.
  6. 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.
  7. Subjects diagnosed with another malignancy in the preceding 5 years will be excluded.
  8. Subjects diagnosed with simultaneous bilateral breast cancer.
  9. Subjects receiving immunosuppressive therapy within 6 months including oral steroids will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856036


Locations
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United States, California
Saint John's Health Center
Santa Monica, California, United States, 90404
Sponsors and Collaborators
John Wayne Cancer Institute
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Responsible Party: John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT01856036    
Other Study ID Numbers: CHUM-CRYOABLATION
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Wayne Cancer Institute:
Ductal Histology
Unifocal
Estrogen Receptor Positive
her2neu negative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases