Spots Global Cancer Trial Database for The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
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Trial Identification
Brief Title: The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
Official Title: The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection
Study ID: NCT03085888
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Mayo Clinic, Phoenix, Arizona, United States
Scottsdale Medical Imaging Research, Scottsdale, Arizona, United States
Sutter Health, Elk Grove, California, United States
Sutter Health, Folsom, California, United States
Sutter Health, Mountain View, California, United States
Sutter Health, Oakland, California, United States
Sutter Health, Palo Alto, California, United States
Sutter Health, Roseville, California, United States
Sutter Health, Sacramento, California, 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
Mayo Clinic, Jacksonville, Florida, United States
Sarah Cannon Research Institute, Snellville, Georgia, United States
Sarah Cannon Research Institute, Overland Park, Kansas, United States
Henry Ford Health System, Dearborn, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Henry Ford Health System, Grosse Pointe Farms, Michigan, United States
Henry Ford Health System, Livonia, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Sarah Cannon Research Institute, Independence, Missouri, United States
Cleveland Clinic, Avon, Ohio, United States
Cleveland Clinic, Beachwood, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Sarah Cannon Research Institute, Charleston, South Carolina, United States
Sarah Cannon Research Institute, Hermitage, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Sarah Cannon Research Institute, McKinney, Texas, United States
Sarah Cannon Research Institute, Salt Lake City, Utah, United States
Sarah Cannon Research Institute, Richmond, Virginia, United States
Sarah Cannon Research Institute, Richmond, Virginia, United States
Sarah Cannon Research Institute, Salem, Virginia, United States
Mayo Clinic, Eau Claire, Wisconsin, United States
Mayo Clinic, La Crosse, Wisconsin, United States
Contact Details
Name: GRAIL Study Director
Affiliation: GRAIL, LLC
Role: STUDY_DIRECTOR
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