The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GRAIL, Inc.
- 入组人数
- 99,481
- 试验地点
- 6
- 主要终点
- To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies).
研究概览
简要总结
GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to develop blood tests to detect cancer early. The purpose of this study is to validate the ability of the pre-specified GRAIL Test to detect breast cancer and other invasive cancers, including hematologic malignancies, that will occur within one year of the first study blood draw.
详细描述
Detection of early stage cancer may be possible through analysis of circulating cell-free nucleic acids (cfNAs) shed into the blood by tumors. GRAIL is using high-intensity sequencing (based on broad genomic coverage and deep sequencing) of cfNAs, combined with machine learning, to develop blood tests to detect cancer early. The purpose of this prospective, multi-center, observational cohort study is to validate an assay for the early detection of breast cancer and other invasive cancers, including hematologic malignancies. The study will collect blood samples from participants within 28 days of their screening mammogram. Additional blood samples will also be collected for a subset of participants. For participants who receive a cancer diagnosis during the study, archival tissue samples will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Women undergoing mammography for screening indications or have an appointment for screening mammography.
- •Participant provides informed consent and expresses understanding of the protocol and its requirements, risks, and discomforts.
排除标准
- 未提供
结局指标
主要结局
To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies).
时间窗: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
To refine the predictive algorithms and cut points of the GRAIL test to detect breast and other invasive cancers (including hematologic malignancies).
时间窗: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
次要结局
- Diagnosis of invasive cancers, including hematologic malignancies, diagnosed in 6-month time windows (e.g. 0-6 months, >6-12 months, >12-18 months, >18-24 months).(From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months)
- Diagnosis of invasive cancers, including hematologic malignancies, diagnosed in To evaluate the performance of the GRAIL Test to detect invasive cancers in clinically meaningful subgroups.(From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months)