A Comprehensive Breast Cancer Survivorship Biorepository
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,300
- 试验地点
- 2
- 主要终点
- Biorepository
研究概览
简要总结
This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes.
详细描述
PRIMARY OBJECTIVE:
I. To create an annotated biorepository with prospectively collected blood samples from breast cancer survivors.
SECONDARY OBJECTIVES:
I. To collect comprehensive data on social determinants of health (e.g., race/ethnicity, acculturation, socioeconomic status, and access to care), environmental exposures (based on zip codes/geocoding), lifestyle (e.g., diet, tobacco use), clinicopathologic characteristics, treatment history, follow-up and current disease status, survivorship-related issues.
II. To establish an efficient process for researchers to utilize the biorepository for breast cancer and survivorship-related studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Women of all racial and ethnic groups 18 years of age or older
- •Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years
- •Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation)
- •Prior participation on clinical trials is allowed
排除标准
- •Current receipt of interventional clinical trial participation
- •Stage IV (metastatic) cancer
- •Prior history of recurrence (except recurrence following ductal carcinoma in situ)
- •Inability to give informed consent
- •Unable to speak English, Spanish, Chinese, or Korean
结局指标
主要结局
Biorepository
时间窗: 5 years
Number of biological samples collected and stored (blood)
次要结局
未报告次要终点