Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 12
- 主要终点
- Modified Quantitative Protein Algorithmic Score (QPAS)
研究概览
简要总结
The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. The biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women from 25 years of age to below 75 years of age
- •Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
- •Study visit and blood collection within 4 weeks (28 days) of ACR BI-RADS assessment
- •Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
- •Samples collected under IRB approval and Informed Consent
- •Testing performed under IRB approval or waiver (as applicable)
- •Previous approved procedures to enroll patients: breast augmentation & cyst aspiration
排除标准
- •Adults from 76 years of age or older and below 25 years of age
- •Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
- •Subjects that have had a breast biopsy performed during the 6 months prior to the study visit
- •Samples not collected under IRB approval and Informed Consent
- •Testing not performed under IRB approval or waiver (as applicable)
- •Prior breast cancer diagnosis.
结局指标
主要结局
Modified Quantitative Protein Algorithmic Score (QPAS)
时间窗: 6 Months
Demonstrate proof-of-concept for use of the dtectDx-Breast Assay to assess likelihood of breast cancer malignancy in conjunction with the physicians clinical and radiological evaluations.
Quantitative Protein Algorithmic Score (QPAS)
时间窗: Baseline
Part I: Establish an acceptable algorithm for the generation of a single numerical score from the combination of the 10 cancer biomarkers that comprise the dtectDx Breast v2.0 Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman
次要结局
- QPAS relative to BI-RADS(Baseline)