NCT02270931已完成不适用
A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Measure CA 15-3 in Breast Cancer Patients
研究概览
简要总结
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer.
详细描述
The study objectives are described below:
- Obtain serum and plasma specimens longitudinally collected from a minimum of 130 subjects diagnosed with breast cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 15-3 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
- To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 15-3 assays, for monitoring the course of disease and therapy in subjects diagnosed with breast cancer.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, age≥ 18 years
- •Histologic/pathologic confirmation of breast cancer
- •Any stage of disease: Newly diagnosed, stable, disease progression, surveillance
- •Any treatment time point: Treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring.
- •Individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible.
- •Able to understand and willing to provide informed consent
排除标准
- •Males and females, age <18 years
- •No histologic/pathologic confirmation of breast cancer
- •Any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer.
- •Treatment plan with fewer than three visits expected in 3 years' time
- •Unable to provide informed consent
结局指标
主要结局
Measure CA 15-3 in Breast Cancer Patients
时间窗: 3 years
130 patients with Recurrence or Progressive Breast Cancer.
次要结局
未报告次要终点
研究者
研究点 (3)
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