Inflammation and Biopsy-site-marker in Breast Cancer (MOSAIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Evaluable Tissue Samples.
研究概览
简要总结
The purpose of this study is to explore pro-metastatic changes in breast cancer (BC) associated with the stiffness of biopsy site markers. This study aims to determine whether the stiffness of a biopsy site marker promotes inflammatory changes in breast cancer and to evaluate whether there is a relationship between biopsy site marker stiffness and inflammation.
详细描述
This prospective study aims to evaluate whether anti-inflammatory and pro-metastatic changes at the post-biopsy site are associated with the type of biopsy-site marker used, with particular focus on marker stiffness. Tissue samples will be collected from breast cancer patients who received a biopsy-site marker at the time of diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (ICF) signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses.
- •Female patients at > 18 years of age at the time of signature of the ICF.
- •Pathologically verified invasive breast cancer cases referred to OU for surgery.
排除标准
- •Patients who had a biopsy at OUBI OKC.
- •Patient who will undergo neoadjuvant therapy
- •Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active viral infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
- •Currently pregnant or breastfeeding
- •Patients not eligible for surgery
- •Prisoners
研究组 & 干预措施
Breast Cancer Patients
140 patients will be assigned to this group.
干预措施: Biopsy-Site Marker Placement. (Device)
结局指标
主要结局
Proportion of Patients With Evaluable Tissue Samples.
时间窗: 1 year
To process 100 surgically resected breast tumors that had needle biopsy and biopsy site marker placement outside OKC downtown campus.
Differences in Stiffness of Tissue Samples Collected During Surgical Biopsy.
时间窗: 1 Year
We will conduct a spatiotemporal analysis of surgically resected tissues to evaluate whether the stiffness of the chemical materials is associated with an anti-inflammatory microenvironment and a higher prevalence of epithelial-mesenchymal transition (EMT) in cancer cells. To better characterize these differences, we will assess phenotypic changes using multiplex immunofluorescence on resected surgical specimens with the biopsy site marker in place, enabling precise spatial localization and comparison of tissue responses over time.
次要结局
- Differences in Gene Expressions From Surgically Resected Tissue in Comparison To Those Associated With EMT.(1 Year)
- Number of Different Variations In Gene Expression From Surgically Resected Tissue Samples.(1 Year)