NCT00041353撤回不适用
Breast Cancer Biomarkers Based on Fine Needle Aspirates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
研究概览
简要总结
RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for breast cancer may improve the ability to detect breast cancer cells early and plan effective treatment.
PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration specimens from women at increased or normal risk of breast cancer.
详细描述
OBJECTIVES:
- Compare specific biomarkers, including cellular morphology (cytology), proliferation index (Ki-67), p53 expression, and LOH in chromosome 9p at locus DS9157, in fine needle aspirate specimens from women at increased vs normal risk of breast cancer.
- Determine whether these specimens are adequate to perform the biomarker assays and whether this technique could be used in the general outpatient setting.
- Determine whether biomarker levels in these patients are concordant or discordant with individual clinical risk of breast cancer.
- Determine whether 1 or more biomarkers can distinguish high-risk from control patients.
- Correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis from the breast biopsy.
OUTLINE: Patients undergo fine needle aspiration of normal appearing breast tissue prior to the beginning of elective surgery. Specimens are analyzed for the presence of specific biomarkers.
PROJECTED ACCRUAL: Approximately 156 patients will be accrued for this study within 3 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Screening
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究者
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