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
1 other identifier
observational
99,481
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Longer than P75 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2017
CompletedStudy Start
First participant enrolled
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedSeptember 20, 2024
September 1, 2024
5.3 years
January 17, 2017
September 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
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
Study Arms (1)
Prospective Cohort
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.
Eligibility Criteria
This multi-center study aims to enroll approximately 100,000 women undergoing mammography for screening indications and associated medical care from participating study centers.
You may qualify if:
- 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.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GRAIL, Inc.lead
Study Sites (35)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Scottsdale Medical Imaging Research
Scottsdale, Arizona, 85258, United States
Sutter Health
Elk Grove, California, 95758, United States
Sutter Health
Folsom, California, 95630, United States
Sutter Health
Mountain View, California, 94040, United States
Sutter Health
Oakland, California, 94609, United States
Sutter Health
Palo Alto, California, 94301, United States
Sutter Health
Roseville, California, 95661, United States
Sutter Health
Sacramento, California, 95816, United States
Sutter Health
San Francisco, California, 94118, United States
Sutter Health
San Mateo, California, 94401, United States
Sutter Health
Santa Cruz, California, 95062, United States
Sutter Health
Santa Rosa, California, 95403, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Sarah Cannon Research Institute
Snellville, Georgia, 30078, United States
Sarah Cannon Research Institute
Overland Park, Kansas, 66209, United States
Henry Ford Health System
Dearborn, Michigan, 48126, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Henry Ford Health System
Grosse Pointe Farms, Michigan, 48326, United States
Henry Ford Health System
Livonia, Michigan, 48150, United States
Mayo Clinic
Rochester, Minnesota, 32224, United States
Sarah Cannon Research Institute
Independence, Missouri, 64057, United States
Cleveland Clinic
Avon, Ohio, 44011, United States
Cleveland Clinic
Beachwood, Ohio, 44122, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Sarah Cannon Research Institute
Charleston, South Carolina, 29406, United States
Sarah Cannon Research Institute
Hermitage, Tennessee, 37076, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute
McKinney, Texas, 75069, United States
Sarah Cannon Research Institute
Salt Lake City, Utah, 84124, United States
Sarah Cannon Research Institute
Richmond, Virginia, 23229, United States
Sarah Cannon Research Institute
Richmond, Virginia, 23235, United States
Sarah Cannon Research Institute
Salem, Virginia, 24153, United States
Mayo Clinic
Eau Claire, Wisconsin, 54702, United States
Mayo Clinic
La Crosse, Wisconsin, 54601, United States
Related Publications (1)
Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.
PMID: 33506766DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
GRAIL Study Director
GRAIL, Inc.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2017
First Posted
March 21, 2017
Study Start
February 28, 2017
Primary Completion
June 30, 2022
Study Completion
April 1, 2024
Last Updated
September 20, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share