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The STRIVE Study: Breast Cancer Screening Cohort

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ClinicalTrials.gov Identifier: NCT03085888
Recruitment Status : Enrolling by invitation
First Posted : March 21, 2017
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):

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 train and validate an assay to detect invasive breast cancer in patients undergoing mammography.

Condition or disease
Invasive Breast Cancer Neoplasm, Breast Cancer, Breast

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 train and validate an assay for the early detection of breast cancer. 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, tissue samples will be collected.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 120000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Diagnosis of invasive breast cancer among women undergoing mammography [ Time Frame: 30 Months Estimated ]
    Clinically annotated plasma samples from participants will undergo high-intensity sequencing to characterize cfNA profiles.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study seeks to enroll 120,000 women undergoing mammography for screening indications and associated medical care from participating study centers.

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085888

United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Scottsdale Medical Imaging - Town Center
Scottsdale, Arizona, United States, 85251
Scottsdale Medical Imaging - Thompson Peak
Scottsdale, Arizona, United States, 85255
Scottsdale Medical Imaging - Sue Levy Breast Center
Scottsdale, Arizona, United States, 85258
United States, California
Sutter Imaging Elk Grove
Elk Grove, California, United States, 95758
Sutter Imaging Folsom II
Folsom, California, United States, 95630
Sutter Palo Alto Medical Foundation Mountain View Breast Center
Mountain View, California, United States, 94040
Carol Ann Read Breast Health Center
Oakland, California, United States, 94609
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301
Sutter Imaging Roseville Parkway
Roseville, California, United States, 95661
Sutter Imaging Sacramento
Sacramento, California, United States, 95816
Sutter Health California Pacific Medical Center
San Francisco, California, United States, 94118
Mills-Peninsula Medical Center
San Mateo, California, United States, 94401
Sutter Health -Palo Alto Medical Foundation
Santa Cruz, California, United States, 95062
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Kansas
Menorah Medical Center
Overland Park, Kansas, United States, 66209
United States, Minnesota
Mayo Clinic - Minnesota
Rochester, Minnesota, United States, 32224
United States, Missouri
Centerpoint Medical Center
Independence, Missouri, United States, 64057
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Tennessee
Tristar Summit Outpatient Center Summit Women's Imaging
Hermitage, Tennessee, United States, 37076
Tristar Centennial Women's Health and Imaging Center
Nashville, Tennessee, United States, 37203
United States, Virginia
Henrico Doctor's Hospital
Richmond, Virginia, United States, 23229
CJW Medical Center
Richmond, Virginia, United States, 23235
United States, Wisconsin
Mayo Health Systems
Eau Claire, Wisconsin, United States, 54702
Mayo Clinic
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Study Director: Brian Allen, MS GRAIL, Inc.
Study Director: Anne-Renee Hartman, MD GRAIL, Inc.

Responsible Party: GRAIL, Inc.
ClinicalTrials.gov Identifier: NCT03085888     History of Changes
Other Study ID Numbers: GRAIL-002
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by GRAIL, Inc.:
Cancer Screening
Next Generation Sequencing
Circulating cell-free nucleic acid
Circulating cell-free tumor DNA
Deep sequencing

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases