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The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types

Sponsor
GRAIL, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03085888
Collaborator
(none)
99,481
Enrollment
35
Locations
98
Anticipated Duration (Months)
2842.3
Patients Per Site
29
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    99481 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection
    Actual Study Start Date :
    Feb 28, 2017
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    May 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. 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]

    2. 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 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. [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). [From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Phoenix Arizona United States 85054
    2 Scottsdale Medical Imaging Research Scottsdale Arizona United States 85258
    3 Sutter Health Elk Grove California United States 95758
    4 Sutter Health Folsom California United States 95630
    5 Sutter Health Mountain View California United States 94040
    6 Sutter Health Oakland California United States 94609
    7 Sutter Health Palo Alto California United States 94301
    8 Sutter Health Roseville California United States 95661
    9 Sutter Health Sacramento California United States 95816
    10 Sutter Health San Francisco California United States 94118
    11 Sutter Health San Mateo California United States 94401
    12 Sutter Health Santa Cruz California United States 95062
    13 Sutter Health Santa Rosa California United States 95403
    14 Mayo Clinic Jacksonville Florida United States 32224
    15 Sarah Cannon Research Institute Snellville Georgia United States 30078
    16 Sarah Cannon Research Institute Overland Park Kansas United States 66209
    17 Henry Ford Health System Dearborn Michigan United States 48126
    18 Henry Ford Health System Detroit Michigan United States 48202
    19 Henry Ford Health System Grosse Pointe Farms Michigan United States 48326
    20 Henry Ford Health System Livonia Michigan United States 48150
    21 Mayo Clinic Rochester Minnesota United States 32224
    22 Sarah Cannon Research Institute Independence Missouri United States 64057
    23 Cleveland Clinic Avon Ohio United States 44011
    24 Cleveland Clinic Beachwood Ohio United States 44122
    25 Cleveland Clinic Cleveland Ohio United States 44195
    26 Sarah Cannon Research Institute Charleston South Carolina United States 29406
    27 Sarah Cannon Research Institute Hermitage Tennessee United States 37076
    28 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    29 Sarah Cannon Research Institute McKinney Texas United States 75069
    30 Sarah Cannon Research Institute Salt Lake City Utah United States 84124
    31 Sarah Cannon Research Institute Richmond Virginia United States 23229
    32 Sarah Cannon Research Institute Richmond Virginia United States 23235
    33 Sarah Cannon Research Institute Salem Virginia United States 24153
    34 Mayo Clinic Eau Claire Wisconsin United States 54702
    35 Mayo Clinic La Crosse Wisconsin United States 54601

    Sponsors and Collaborators

    • GRAIL, LLC

    Investigators

    • Study Director: GRAIL Study Director, GRAIL, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GRAIL, LLC
    ClinicalTrials.gov Identifier:
    NCT03085888
    Other Study ID Numbers:
    • GRAIL-002
    First Posted:
    Mar 21, 2017
    Last Update Posted:
    Jul 31, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Jul 31, 2020