Cancer, Neoplasms
Conditions
Keywords
Cancer Screening, High-Throughput Nucleotide Sequencing, Deep Sequencing, Circulating cell-free tumor DNA
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
GRAIL, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Women undergoing mammography for screening indications or have an appointment for screening mammography. 2. Participant provides informed consent and expresses understanding of the protocol and its requirements, risks, and discomforts.
Exclusion criteria
None.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies). | 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). | From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | sequencing to characterize cfNA profiles. |
| 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 | — |
Countries
United States
Outcome results
None listed