The STRIVE Study: Breast Cancer Screening Cohort
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03085888 |
Recruitment Status
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Enrolling by invitation
First Posted
: March 21, 2017
Last Update Posted
: April 19, 2018
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Condition or disease |
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Invasive Breast Cancer Neoplasm, Breast Cancer, Breast |
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 |

Group/Cohort |
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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.
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- 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.

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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 |
Inclusion Criteria:
- 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.
Exclusion Criteria:

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 | |
Lewis Gale Medical Center | |
Salem, Virginia, United States, 24153 | |
United States, Wisconsin | |
Mayo Health Systems | |
Eau Claire, Wisconsin, United States, 54702 | |
Mayo Clinic | |
La Crosse, Wisconsin, United States, 54601 |
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: | April 19, 2018 |
Last Verified: | April 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 Neoplasms Breast Diseases Skin Diseases |