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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasms, Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Cohort<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). |  | From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Screening, High-Throughput Nucleotide Sequencing, Deep Sequencing, Circulating cell-free tumor DNA