The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
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ClinicalTrials.gov Identifier: NCT03085888 |
Recruitment Status :
Active, not recruiting
First Posted : March 21, 2017
Last Update Posted : October 17, 2022
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Condition or disease |
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Neoplasms Cancer |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 99481 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 |
Actual Primary Completion Date : | June 30, 2022 |
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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- To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies). [ Time Frame: 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). [ Time Frame: 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 To evaluate the performance of the GRAIL Test to detect invasive cancers in clinically meaningful subgroups. [ Time Frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months ]sequencing to characterize cfNA profiles.
- 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). [ Time Frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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:
None.

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

Study Director: | GRAIL Study Director | GRAIL, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GRAIL, LLC |
ClinicalTrials.gov Identifier: | NCT03085888 |
Other Study ID Numbers: |
GRAIL-002 |
First Posted: | March 21, 2017 Key Record Dates |
Last Update Posted: | October 17, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cancer Screening High-Throughput Nucleotide Sequencing Deep Sequencing Circulating cell-free tumor DNA |