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

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 : Active, not recruiting
First Posted : March 21, 2017
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
GRAIL, Inc.

Tracking Information
First Submitted Date January 17, 2017
First Posted Date March 21, 2017
Last Update Posted Date May 1, 2019
Actual Study Start Date February 28, 2017
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2019)
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.
Original Primary Outcome Measures
 (submitted: March 15, 2017)
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.
Change History Complete list of historical versions of study NCT03085888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 29, 2019)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
Official Title The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
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.
Condition
  • Neoplasms
  • Cancer
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 29, 2019)
99481
Original Estimated Enrollment
 (submitted: March 15, 2017)
120000
Estimated Study Completion Date May 2025
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03085888
Other Study ID Numbers GRAIL-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party GRAIL, Inc.
Study Sponsor GRAIL, Inc.
Collaborators Not Provided
Investigators
Study Director: Brian Allen, MS GRAIL, Inc.
Study Director: Anne-Renee Hartman, MD GRAIL, Inc.
PRS Account GRAIL, Inc.
Verification Date April 2019