Core Biopsies of Breast Tumor Tissue Repository
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Development and maintenance of a secure clinical database of relevant demographic, clinical, pathologic, and longitudinal outcome characteristics of the samples to be banked
研究概览
简要总结
This research trial establishes a breast tumor tissue repository from core biopsies. Collecting breast tissue from core biopsies may allow doctors to learn more about the biology of breast cancer and to analyze proteins, genes, and other components of tumor cells. It may also allow doctors to conduct future studies to help understand how breast cancer grows and how it responds to different types of therapy. This will help doctors develop better breast cancer therapies and better tests to help make treatment decisions.
详细描述
PRIMARY OBJECTIVES:
I. To develop a baseline and serial breast cancer core biopsy repository within the University of Southern California (USC)/Norris Comprehensive Cancer Center Women's Cancer Program.
II. To develop and maintain a secure clinical database of relevant demographic, clinical, pathologic and longitudinal outcome characteristics of the samples to be banked.
III. To have an efficient process for the distribution of de-identified samples from the bank to researchers with institutional review board (IRB)-approved protocols or exemptions for the study of breast cancer-related questions. These studies would include analyses of tumor proteins and nucleic acids, serum/plasma and germline deoxyribonucleic acid (DNA) and immune cells in relationship to other baseline and follow-up clinical and pathological variables.
OUTLINE: Patients are assigned to 1 of 4 cohorts.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Known or suspected breast cancer
- •Known or suspected metastatic solid tumor that originated in the breast per the patient's medical history
排除标准
- •Inability to sign informed consent
- •Known bleeding disorder
- •Use of anticoagulant medications (heparin, warfarin, etc.) within one week prior to biopsy
- •Use of antiplatelet medications (aspirin, clopidogrel, etc.) within one week prior to biopsy
结局指标
主要结局
Development and maintenance of a secure clinical database of relevant demographic, clinical, pathologic, and longitudinal outcome characteristics of the samples to be banked
时间窗: Up to 10 years
Development of an efficient process for the distribution of de-identified samples from the bank to researchers with IRB-approved protocols or exemptions for the study of breast cancer-related questions
时间窗: Up to 10 years
Development of a baseline and serial breast cancer core biopsy repository within the USC/Norris Comprehensive Cancer Center Women's Cancer Program
时间窗: Up to 10 years
次要结局
未报告次要终点