UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058614 |
|---|---|
| Receipt number | R000067023 |
| Scientific Title | Mechanistic Analysis of Antigen-Specific T Cell Response Regulation by Alpha-2-glycoprotein 1, Zinc-binding in Breast Cancer |
| Date of disclosure of the study information | 2025/07/28 |
| Last modified on | 2025/07/28 11:58:12 |
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Basic information
Public title
Analysis of the Impact of Alpha-2-glycoprotein 1, Zinc-binding on T Cell Immune Responses in Breast Cancer
Acronym
ZAG-T cell Regulation in Breast Cancer
Scientific Title
Mechanistic Analysis of Antigen-Specific T Cell Response Regulation by Alpha-2-glycoprotein 1, Zinc-binding in Breast Cancer
Scientific Title:Acronym
Regulatory Mechanisms of T Cell Immune Responses Mediated by ZAG in Breast Cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
An exploratory basic research study to investigate the functional and molecular impact of ZAG on antigen-specific T cell responses.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Hanamura |
Organization
School of Medicine, Tokai University
Division name
Department of Breast Oncology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463931121
hanamura.toru.w@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Hanamura |
Organization
Tokai University
Division name
Department of Breast Oncology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463931121
Homepage URL
hanamura.toru.w@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
046393112
tokai-rec@tokai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
神奈川県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None in particular.
Management information
Registered date
| 2025 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067023
