Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 8
- 主要终点
- Training
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 in your blood samples. The biomarker 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.
详细描述
As part of the study, 35 mL or 2 1/2 tablespoons of blood will be drawn from your arm at each study visit.
This study has 2 visits. Visit 1 will take about 1 hour. Visit 2 is a follow up visit at 6 months taking about 1 hour.
Visit 1- Screening and Blood Collection:
The following procedures will be done at the clinical research facility:
- The study doctor and/or study staff will explain the study and all the study procedures.
- You will be asked to review, sign and date this informed consent before any procedures are done.
- The study doctor and/or study staff will ask you questions about your health status and medical history and record this information.
- 35 mL or 2 ½ tablespoons of blood will be collected from your arm.
- The samples will not be labeled with your name but a unique identification code, which means they will be given a number which can be linked to you.
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 49 Years（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 50 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 3 weeks (21 days) of ACR BI-RADS assessment
- •Patient agrees to return for diagnostic follow-up and blood collection at 6 months unless a positive cancer diagnosis is made between study visits 1 and
- •Individuals diagnosed with LCIS and DCIS will agree to return for visit 2
- •Samples collected under IRB approval and Informed Consent
- •Testing performed under IRB approval or waiver (as applicable)
排除标准
- •Adults from 50 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 at any time 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
Training
时间窗: Baseline
Part I: Establish an acceptable algorithm for generation of a single numerical score from the combination of the 5 cancer biomarkers that comprise the dtectDX-Breast Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman.
Blinded Validation
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.
次要结局
- Clinical Sensitivity/Specificity(Baseline)