De-convoluting Interactions Between Genes, the Cancer Environment, and the Immune System to Develop Therapies That Work for You
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
- establish a live biobank for breast cancer patients
研究概览
简要总结
This is a live biobank study for breast cancer (BC) patients where samples will be collected at inflection points in the course of the disease.
详细描述
To test this hypothesis the investigators will focus on studying BC patients using an innovative approach, the DIGNITY Study (De-convoluting interactions between genes, the cancer environment, and the immune system to develop therapies that work for you) designed to building a live tissue biobank of Patient Derived Tumor Organoids (PDOs) derived from tumor at surgery, preceded or not by neoadjuvant therapy (NAT), and at recurrence/metastasis. BC patients enrolled in this study are consented to enable investigators to generate a biobank of tumor tissue (obtained from surgically removed excess that would otherwise be disposed off ) and matched blood cells ( obtained from an already existing line or a venipuncture ordered per standard of care testing) at key timepoints in their treatment course.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients will historically proven BC are eligible to be on the study
排除标准
- •Carriers of other cancers other than breast.
结局指标
主要结局
establish a live biobank for breast cancer patients
时间窗: 60 months
Tumor tissue will be obtained at key inflection points from breast cancer patients (BC): at initial diagnosis, at surgery and at metastasis or recurrence. Patient Derived Organoids (PDOs) will be prepared from tumors that are obtained from the BC patients.
次要结局
- assess immune relevant genes from tumor biopsies(60 months)