Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

This is a prospectively enrolling cohort study with a pre-specified molecular analysis plan. A stratified case-cohort design will be employed to select cancer cases and non-cancer subjects who will be assayed. All cases of cancer (breast and non-breast cancer) will be selected. A random subset of the overall study cohort will also be selected.

GRAIL Study Director

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.

The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types

The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection

sequencing to characterize cfNA profiles.

GRAIL, LLC

Participants with new diagnosis of cancer (multiple tumor types) from which a blood sample and contemporaneous FFPE tumor tissue will be collected.

Participants with no known diagnosis or past history of cancer from which a blood sample will be collected.

Eric Fung, MD, PhD

GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from participants with a new diagnosis of cancer (blood and tumor tissue) and from participants who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer participants and to develop models for distinguishing cancer from non-cancer.

This is a prospective, multi-center, observational study with collection of de-identified biospecimens and clinical data from at least 15,000 participants from clinical networks in the United States and Canada. The study will enroll approximately 10,500 cancer participants (CANCER arm) and approximately 4,500 representative participants without a clinical diagnosis of cancer (NON-CANCER arm). Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (time of biospecimen collection), and subsequently from the medical record at intermittent future time points, at least annually for up to 5 years.

Plasma, white blood cells, formalin fixed, paraffin embedded (FFPE) tumor tissue

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types	NCT03085888	Neoplasms Cancer		18 Years -	GRAIL, LLC
The Circulating Cell-free Genome Atlas Study	NCT02889978	Neoplasms Cancer		20 Years -	GRAIL, LLC

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