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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 : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
GRAIL, Inc.

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.

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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 : February 2020
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Diagnosis of invasive cancer, including hematologic malignancies within one year after the first study blood draw. [ Time Frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months ]
    Clinically annotated plasma samples from participants will undergo high-intensity sequencing to characterize cfNA profiles.


Secondary Outcome Measures :
  1. Diagnosis of invasive cancers, including hematologic malignancies, that occur between 12 and 24 months after the first study blood draw, and cancer-specific mortality. [ Time Frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months ]
    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, 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.


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


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Sponsors and Collaborators
GRAIL, Inc.
Investigators
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Study Director: Brian Allen, MS GRAIL, Inc.
Study Director: Anne-Renee Hartman, MD GRAIL, Inc.

Additional Information:

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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: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GRAIL, Inc.:
Cancer Screening
High-Throughput Nucleotide Sequencing
Deep Sequencing
Circulating cell-free tumor DNA