Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity & Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,458
- 试验地点
- 7
- 主要终点
- Screening performance (i.e., sensitivity and specificity)
研究概览
简要总结
POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. The present study aims to determine the Sensitivity and Specificity of the test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.
详细描述
2400 subjects will be screened for breast cancer in seven enrolling sites across the country to ensure diverse ethnicity.
"Positive" subjects should be confirmed breast cancer positive by Mammography and/or biopsy. Breast cancer positive samples will be compared to the control group of samples obtained from women attending clinics for non-cancerous related pathology.
Both Positive and Negative Predictive Values will be evaluated to determine accuracy and sensitivity of the screening test.
Subjects whose known cancer positive or negative status do not match the test report will be followed up as appropriate, on case by case basis to identify false positive and false negative results.
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
- •Ability to give informed consent. Written informed consent by the patient/patient's legally acceptable representative (LAR) for donating blood sample
- •Documented absence of cancer (other than Breast Cancer)
- •Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any stage
- •Blood sample taken before any treatment for Breast Cancer was administered to the subject.
排除标准
- •Other malignancy besides breast cancer in the 5 years prior to obtaining the sample.
- •Therapies for breast cancer that have been administered within 1 year of obtaining the sample
- •Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating in the study.
结局指标
主要结局
Screening performance (i.e., sensitivity and specificity)
时间窗: Screening performance will be calculated at 4-months
Screening performance: comprises the sensitivity and specificity of MammoAlert™. It represents the performance of the diagnostic test and is therefore independent of the prevalence of the disease in the studied sample of patients.
次要结局
- Predictive values & likelihood ratios(Predictive values & likelihood ratios will be calculated at 4-months)