NCT00472589已完成不适用
A Biological Sample Collection Protocol of Women With and Without Breast Cancer: Hoosier Oncology Group Study BRE06-120 for the Analytical Proteomics Team
Hoosier Cancer Research Network11 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2007年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 11
研究概览
简要总结
The purpose of this trial is to collect plasma, serum, whole blood and tissue samples from women with breast cancer and plasma, serum, whole blood from healthy women, which will be made available to researchers for biomarker analysis.
详细描述
OUTLINE: This is a multi-center study.
The treatment plan for each breast cancer subject will be determined at the discretion of the treating physician and subject. This protocol does not prescribe any particular standard of care treatment.
There will be no treatment for the healthy volunteers.
研究设计
- 研究类型
- Observational
- 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
- 是
入选标准
- •FOR WOMEN WITH BREAST CANCER
- •Histologically or cytologically confirmed invasive malignancy or ductal carcinoma in situ of the breast.
- •Preparing to begin a new regimen for breast cancer (adjuvant, locally recurrent, any line metastatic).
- •Age > 18 years at the time of consent.
- •Written informed consent and HIPAA authorization for release of personal health information.
- •FOR HEALTHY VOLUNTEERS
- •No known history of invasive malignancy or ductal carcinoma in situ. Volunteers must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled as healthy volunteers.
- •Age > 18 years at the time of consent.
- •Written informed consent and HIPAA authorization for release of personal health information.
排除标准
- •Females must not be pregnant.
研究者
研究点 (11)
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