Autoantibodies in Breast Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,279
- 试验地点
- 1
- 主要终点
- Autoantibodies for breast cancer diagnosis
研究概览
简要总结
Prospective, single-center study in women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram. We are no longer enrolling women who had normal Screening mammograms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Inclusion Criteria:
- •All Cohorts:
- •Women age 18 and older
- •Understand and provide informed consent and HIPAA Authorization prior to initiation of any study-specific procedures
- •Recent abnormal mammogram followed by a breast biopsy
- •Initial diagnosis of Stage I, II, III or IV invasive breast cancer
- •Recent abnormal mammogram followed by a breast biopsy
- •Diagnosed benign breast tumor with high-risk pathology. This would include, but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), flat epithelia atypia and phylloides
- •Recent abnormal mammogram followed by a breast biopsy
- •Diagnosed benign breast tumor. This would include, but is not limited to, fibroadenoma, papilloma, fibrocystic changes, and Pseudoangiomatous stromal hyperplasia (PASH)
- •Normal screening mammogram within the last 6 months
排除标准
- •All Cohorts:
- •Unable or unwilling to give written informed consent
- •History of cancer other than non-melanoma basal or squamous cell skin carcinoma, ductal carcinoma in situ (DCIS) and cervical carcinoma in situ.
- •History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
- •History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
- •History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
- •History of or current autoimmune disease including but not limited to Sjogrens Syndrome, Systemic Sclerosis (SSc), Scleroderma (Scl) and Dermatomyositis, Systemic Lupus Erythematosus, Multiple Sclerosis, Type I Diabetes, Rheumatoid Arthritis
- •History of abnormal mammogram
结局指标
主要结局
Autoantibodies for breast cancer diagnosis
时间窗: 5 years
The data from Phase I will be tested and validated with newly diagnosed BCa patient samples from Cohort A, and age-matched healthy controls taken from Cohort D, and a risk score will be developed based on a composite of autoantibodies for breast cancer diagnosis. A Cox Proportional Hazards (PH) Regression will be used to analyze a case-cohort study design to validate the risk score by identifying breast cancer cases from those cases in Cohorts B, C and D.
次要结局
未报告次要终点