Peptide Profiles of Women Undergoing Breast Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 571
- 试验地点
- 1
- 主要终点
- To identify the peptide profile associated with a diagnosis of malignancy on breast biopsy.
研究概览
简要总结
This study is being done to learn about blood proteins. We want to see if the blood proteins in women whose biopsies show breast cancer are different from the blood proteins in women whose biopsies do not show breast cancer. The goal of this study is to develop a blood test than can help detect breast cancers when they are very small and easy to cure.
详细描述
Despite currently available screening techniques, only 63% of breast cancer cases are diagnosed at a localized stage, for which the 5-year survival rate exceeds 95% (1). Advances in breast imaging are occurring, but further efforts to detect breast cancer at an early stage would be beneficial. Recently, new technologies which use mass spectrometric analysis to characterize the overall pattern of peptide expression in the serum or plasma have been developed. Preliminary studies have suggested that peptide profiles can be used to differentiate cancer patients from those without cancer for a variety of malignancies including breast cancer. If mass spectrometric analysis is able to detect differences in peptide profiles between early stage breast cancers and normal controls, this technique could be developed as a screening modality.
The objective of the present study which is entitled "Peptide Profiles of Women Undergoing Breast Biopsy" is to determine whether the diagnosis of malignancy on breast biopsy is associated with a specific serum or plasma peptide profile which can be distinguished from the peptide profile associated with benign diagnoses on breast biopsy. To accomplish this, blood samples will be collected from 500 women undergoing breast biopsy and 100 women with metastatic disease. Samples will be obtained prior to the biopsies and analyzed by mass spectrometry. Residual material will be shared with investigators of the National Cancer Institute Clinical Proteomics Technology Assessment Consortium.
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
- •Age ≥ or = to 18
- •Cohort A: Biopsy Cohort:
- •Referred by a healthcare provider for breast biopsy
- •No prior history of invasive breast cancer OR of ductal carcinoma in situ
- •No prior history of other malignancies within 5 years except cervical dysplasia, squamous cell carcinoma of the skin or basal cell carcinoma of the skin Cohort B: Metastatic Disease Cohort - Diagnosis of stage IV breast cancer
排除标准
- •Age < 18
结局指标
主要结局
To identify the peptide profile associated with a diagnosis of malignancy on breast biopsy.
时间窗: 2 years
次要结局
未报告次要终点
