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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03085888
• Other study ID #: GRAIL-002
• Status: Active, not recruiting
• Start date: February 28, 2017
• Est. completion date: May 2025

Study information

• Verified date: October 2022
• Source: GRAIL, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99481
• Est. completion date: May 2025
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Locations

Country	Name	City	State
United States	Cleveland Clinic	Avon	Ohio
United States	Cleveland Clinic	Beachwood	Ohio
United States	Sarah Cannon Research Institute	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Health System	Dearborn	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	Mayo Clinic	Eau Claire	Wisconsin
United States	Sutter Health	Elk Grove	California
United States	Sutter Health	Folsom	California
United States	Henry Ford Health System	Grosse Pointe Farms	Michigan
United States	Sarah Cannon Research Institute	Hermitage	Tennessee
United States	Sarah Cannon Research Institute	Independence	Missouri
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	La Crosse	Wisconsin
United States	Henry Ford Health System	Livonia	Michigan
United States	Sarah Cannon Research Institute	McKinney	Texas
United States	Sutter Health	Mountain View	California
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Sutter Health	Oakland	California
United States	Sarah Cannon Research Institute	Overland Park	Kansas
United States	Sutter Health	Palo Alto	California
United States	Mayo Clinic	Phoenix	Arizona
United States	Sarah Cannon Research Institute	Richmond	Virginia
United States	Sarah Cannon Research Institute	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Sutter Health	Roseville	California
United States	Sutter Health	Sacramento	California
United States	Sarah Cannon Research Institute	Salem	Virginia
United States	Sarah Cannon Research Institute	Salt Lake City	Utah
United States	Sutter Health	San Francisco	California
United States	Sutter Health	San Mateo	California
United States	Sutter Health	Santa Cruz	California
United States	Sutter Health	Santa Rosa	California
United States	Scottsdale Medical Imaging Research	Scottsdale	Arizona
United States	Sarah Cannon Research Institute	Snellville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GRAIL, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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