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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 : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
GRAIL, LLC

Study Description
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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.

Condition or disease
Neoplasms Cancer

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.
Study Design
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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
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. 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 ]

Eligibility Criteria
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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
Study Population
This multi-center study aims to enroll approximately 100,000 women undergoing mammography for screening indications and associated medical care from participating study centers.
Criteria

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:

None.

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
GRAIL, LLC
Investigators
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Study Director: GRAIL Study Director GRAIL, LLC
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GRAIL, LLC:
Cancer Screening
High-Throughput Nucleotide Sequencing
Deep Sequencing
Circulating cell-free tumor DNA