AURORA US: Prospective Biospecimen Repository in Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 300
- 试验地点
- 26
- 主要终点
- Comprehensive biorepository creation
研究概览
简要总结
This trial collects clinical information and tissue and blood samples from patients with breast cancer that has come back or is stage IV. Collecting clinical information and biospecimen samples to create a registry may help doctors better understand the mechanism of tumor spread and determine why people respond differently to specific cancer treatments.
详细描述
PRIMARY OBJECTIVES:
I. To create a comprehensive registry that includes patient demographics, clinical and histopathological data, blood samples, and tissue specimens from the primary tumor and metastatic sites of patients with metastatic breast cancer to improve our understanding of the mechanisms of tumor metastasis and therapeutic resistance.
II. To conduct genomic studies of paired primary tumors and distant metastatic sites.
III. To conduct genomic studies of paired distant metastatic sites obtained during the course of an individual's disease.
IV. To conduct genomic studies of cell free deoxyribonucleic acid (DNA), circulating tumor cell (CTC) derived DNA, germline DNA, and immune based markers in the peripheral circulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Histologically confirmed or suspected invasive breast cancer
- •Radiographic evidence of distant metastatic disease
- •Clinical or radiographic evidence of disease progression OR presenting with de novo stage IV disease
- •Available archived tissue from the initial breast primary (formalin fixed paraffin embedded [FFPE] tissue is acceptable; fresh frozen tissue is preferred if available)
- •Accessible lesion representative of recurrent or metastatic breast cancer for biopsy
- •Type 1 specimen collection: Patients undergoing a clinically directed tissue biopsy or tissue collection who are willing to have additional specimens taken for research during the same procedure. Sites for tissue acquisition may include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, lung, brain, pleural fluid, and ascites as needed for routine clinical care
- •Type 2 specimen collection: Patients undergoing a tissue biopsy or tissue collection for research purposes only. Sites for tissue acquisition include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, pleural fluid, and ascites. Research directed lung biopsies and brain biopsies are not permitted. Procedures for tissue acquisition are restricted to those performed under local anesthesia or intravenous (IV) conscious sedation; biopsies that require general anesthesia are not permitted in this situation
- •Previous cytologic confirmation of malignant pleural effusion or ascites if that is the planned source of fresh specimen collection for study participation
- •Age 18 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Ability to understand and the willingness to sign an informed consent document
排除标准
- •Concurrent disease or condition that in the opinion of the treating oncologist or the provider performing the biopsy procedure renders the patient inappropriate for study participation
- •Concurrent serious medical or psychiatric disorder that may interfere with the subject's safety during the biopsy or tissue collection procedure
- •Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- •History of a serious or life-threatening allergic reaction to local anesthetics (e.g., lidocaine, xylocaine) used during a biopsy procedure
- •Pregnancy (due to the risk of conscious sedation or anesthesia to mother and fetus)
- •Any condition or laboratory finding that in the opinion of the treating oncologist or the provider performing the biopsy procedure would make participation in this protocol hazardous for the patient
研究组 & 干预措施
Observational (biospecimen, clinical info collection)
Patients' archival and newly collected tissue and blood samples are collected periodically for genetic testing. Patients also undergo collection of clinical information within 30 days of biopsy procedure and every 4 months.
干预措施: Biospecimen Collection (Procedure)
Observational (biospecimen, clinical info collection)
Patients' archival and newly collected tissue and blood samples are collected periodically for genetic testing. Patients also undergo collection of clinical information within 30 days of biopsy procedure and every 4 months.
干预措施: Medical Chart Review (Other)
结局指标
主要结局
Comprehensive biorepository creation
时间窗: Up to 2 years
Will create a comprehensive biorepository that includes blood, archival tissue, fresh tissue, and linked molecular and clinical data from patients with recurrent and/or metastatic breast cancer.
次要结局
未报告次要终点