CHUM-CRYOABLATION: Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers
Determine number (percentage via flow cytometry), phenotype and functionality of tumor infiltrating lymphocytes in ablated breast cancer Determine number (percentage via flow cytometry)and phenotype of APC in ablated breast cancer Characterize cytokine and chemokine expression (in IU) in ablated tissue and in pre-ablated and post-ablated serum over time 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) Determine morphology and histology of regional lymph node after cryoablation
United States: Food and Drug Administration
|Saint John's Health Center||Santa Monica, California 90404|