Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058614) titled 'Analysis of the Impact of Alpha-2-glycoprotein 1, Zinc-binding on T Cell Immune Responses in Breast Cancer' on July 28.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Tokai University

Condition: Condition - Breast Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Immune checkpoint inhibitors (ICIs) are effective in some breast cancers, but resistance is linked to hormone receptor signaling and immunosuppressive tumor microenvironments (TME). We previously showed that AR-dependent secretion of ZAG (alpha-2-glycoprotein 1) correlates with immunosuppressive TME features. This study investigates whether ZAG affects antigen-specific T cell responses and explores the underlying mechanisms in vitro. The results may help establish ZAG as a predictive marker for ICI efficacy or as a novel immunotherapeutic target. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Female Key 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. Key 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.

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 28 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067023

Disclaimer: Curated by HT Syndication.