Breast Cancer
Conditions
Interventions
None listed
Sponsors
Tokai University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: A. Inclusion criteria for healthy volunteers Individuals aged 20 years or older who are in good health, have received a full explanation of the purpose and details of the study, and have voluntarily provided written informed consent. B. Inclusion criteria for breast cancer patients Patients with a confirmed diagnosis of breast cancer, regardless of clinical stage, who are capable of providing a sufficient volume of blood samples for the study, have received a full explanation of the purpose and details of the study, and have voluntarily provided written informed consent.
Exclusion criteria
Exclusion criteria: A. Exclusion criteria for healthy volunteers Individuals will be excluded if they are under 20 years of age, have taken corticosteroids, immunosuppressive agents, sex hormone preparations, or endocrine therapy agents within the past three months, have a condition potentially associated with systemic immune dysfunction such as primary immunodeficiency, HIV infection, or a history of hematologic malignancies, or have a history of any malignant tumor. B. Exclusion criteria for breast cancer patients Individuals will be excluded if they have taken corticosteroids, immunosuppressive agents, or sex hormone preparations within the past three months-except for corticosteroids used as antiemetics during intravenous chemotherapy - or if they have a condition potentially associated with systemic immune dysfunction such as primary immunodeficiency, HIV infection, or a history of hematologic malignancies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this study, we aim to clarify the impact of ZAG (Alpha-2-glycoprotein 1, zinc-binding) on antigen-specific T cell responses and its underlying molecular mechanisms, focusing on both HLA class I and class II pathways. Specifically, peripheral blood mononuclear cells (PBMCs) from healthy donors will be stimulated with CEF peptides (class I) and CEFT peptides (class II) to activate CD8 positive and CD4 positive T cells, respectively. The T cell responses, with or without recombinant ZAG, will be quantitatively assessed based on the expression of activation markers (CD25, CD69) and IFN gamma production using ELISPOT and flow cytometry (Experiments A and B). To examine whether ZAG affects antigen processing by antigen presenting cells, we will perform a supplementary assay (Experiment C) using CPI, a stimulation system based on full length antigens derived from cytomegalovirus, parainfluenza, and influenza. Additionally, PBMCs from breast cancer patients will be used to evaluate ZAG effects on responses to tumor associated antigens (TAA) such as Trop2, MUC1, and HER2 (Experiment D). Antigens and donors will be selected based on HLA restriction, using simplified HLA typing with allele specific antibodies. | — |
Countries
Japan
Contacts
Public ContactToru Hanamura
Tokai University Department of Breast Oncology
Outcome results
None listed