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.
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.
Study Type
OBSERVATIONAL
Enrollment
99,481
To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies).
Time frame: 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).
Time frame: 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.
sequencing to characterize cfNA profiles.
Time frame: 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 6-month time windows (e.g. 0-6 months, >6-12 months, >12-18 months, >18-24 months).
Time frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
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