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

Active, not recruiting

• Conditions: Cancer; Neoplasms

• Registration Number: NCT03085888
• Lead Sponsor: GRAIL, Inc.

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.

Study Timeline

• Study First Submitted: 2017-01-17
• Study Start: 2017-02-28
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-21
• Primary Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-17
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 99481

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.

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Exclusion Criteria

None.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (6)

Mayo Clinic; 🇺🇸 La Crosse, Wisconsin, United States

Sutter Health; 🇺🇸 Santa Rosa, California, United States

Scottsdale Medical Imaging Research; 🇺🇸 Scottsdale, Arizona, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Sarah Cannon Research Institute; 🇺🇸 Salem, Virginia, United States

Henry Ford Health System; 🇺🇸 Livonia, Michigan, United States