NCT03085888

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99,481 (actual)
• Sponsor: GRAIL, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Neoplasms
• Cancer

Timeline

• Start date: 2017-02-28
• Primary completion: 2022-06-30
• Completion: 2024-04-01
• First posted: 2017-03-21
• Last updated: 2024-09-20

Locations

35 sites across 1 country: United States