Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 5
- 主要终点
- Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity
研究概览
简要总结
Detecting cancer as early as possible is key to achieving positive outcomes in response to diagnosis and treatment. The current project is aimed at validating a novel blood-based breast cancer identification test (Syantra DX Breast Cancer) that has been developed by Syantra Inc. Syantra DX Breast Cancer measures gene expression signatures in whole blood, and has been retrospectively demonstrated in 780 samples. The test uses proprietary algorithms to analyse gene expression characteristics from a novel multi-biomarker panel, and then classify a sample as positive or negative for breast cancer. Based upon test performance in a retrospective environment, a prospective validation study is being proposed.
The primary objective of this study is to validate Syantra DX Breast Cancer methodology and biomarker panel using prospective samples, well categorized by diagnostic imaging scores, pathology outcomes, and subject characteristics.
详细描述
The current project is aimed at validating Syantra DX Breast Cancer in a screening population. Syantra DX Breast Cancer measures gene expression signatures in whole blood, and has been retrospectively demonstrated in 780 samples. The test uses proprietary algorithms to analyse gene expression characteristics from a novel multi-biomarker panel, and then classify a sample as positive or negative for breast cancer. Based upon test performance in a retrospective environment, a prospective validation study is being proposed, and is described below.
The study seeks to evaluate performance of Syantra DX Breast Cancer in prospective samples and to optimize test methodology and biomarkers. Key to performance of the study is recruitment of women who provide a blood sample around the time of a screening mammogram. Some women have received an abnormal mammography report, and have been classified under the UK Royal College of Radiologists Breast Group (RCRBG) or BI-RADS scoring system in categories 3 - 5. This will support the ability to employ the test for breast cancer detection in a screening/call-back environment. To complete the study cohort, additional women will be recruited from the population who have normal or benign mammography results (RCRBG category 1 and 2), and/or a recent normal physical breast exam, with no history of breast cancer. Blood samples will be acquired from all women following completion of an informed consent procedure.
For those with an abnormal mammogram, blood will be drawn before a biopsy is performed. All sample information will be de-identified, and the samples will be processed and analysed according to Syantra DX Breast Cancer standard operating procedures. These procedures include extracting sample RNA and aliquoting for storage in a manner that maintains sample anonymity. All processing and analysis will be conducted in a blind environment without knowing the associated RCRBG or pathology outcomes for any samples. Only after testing is complete will sample classifications be revealed. Syantra DX Breast Cancer results will then be compared to RCRBG/BI-RADs, biopsy and pathology data to determine performance, and statistics will be calculated.
There is an optional part of the study procedure that is included as 'additional research'. A specific question seeking approval for the additional research is included on the study consent form. For individuals who agree to participate in the additional research, material extracted from their blood sample will be stored for additional investigations.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 30-75 years
- •Normal breast examination - No cancer detected/suspected by physical exam, diagnostic radiology or screening mammography
- •Women with suspected Invasive Breast Cancer
- •Individuals with an abnormal or suspicious mammogram
- •Abnormal screening mammogram with suspected benign breast disease or proliferative changes
排除标准
- •Cancer diagnosis
- •Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)
- •Previous history of any cancer
- •Concomitant or other concurrent anti-cancer therapy
- •Inoperable or inflammatory breast cancer
结局指标
主要结局
Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity
时间窗: through completion of the study, approximately eighteen months
The number of participants that test positive or negative for breast cancer with the Syantra DX Breast Cancer test and their breast cancer status as assessed by mammography or pathology.
Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity
时间窗: through completion of the study. Individual participant data for primary outcome recorded about 18 months from enrollment.
The number of participants that test positive or negative for breast cancer with the Syantra DX Breast Cancer test and their breast cancer status as assessed by mammography or pathology.
次要结局
- Modulate test methodology to account for differences between retrospective and prospective samples(through completion of the study, approximately eighteen months)
- Performance of the Syantra DX Breast Cancer test in prediction of molecular subtype of breast cancer as assessed by pathology(through completion of the study, approximately eighteen months)