Clinical trial NCT03085888: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Cancer
Keywords: Cancer Screening
High-Throughput Nucleotide Sequencing
Deep Sequencing
Circulating cell-free tumor DNA
Lead sponsor: GRAIL, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-21
Enrollment: 99481
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies).
timeFrame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
measure: To refine the predictive algorithms and cut points of the GRAIL test to detect breast and other invasive cancers (including hematologic malignancies).
timeFrame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
Secondary outcomes:
measure: 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.
timeFrame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
measure: 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).
timeFrame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging Research
state: Arizona
city: Elk Grove
country: United States
facility: Sutter Health
state: California
city: Folsom
country: United States
facility: Sutter Health
state: California
city: Mountain View
country: United States
facility: Sutter Health
state: California
city: Oakland
country: United States
facility: Sutter Health
state: California
city: Palo Alto
country: United States
facility: Sutter Health
state: California
city: Roseville
country: United States
facility: Sutter Health
state: California
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: San Francisco
country: United States
facility: Sutter Health
state: California
city: San Mateo
country: United States
facility: Sutter Health
state: California
city: Santa Cruz
country: United States
facility: Sutter Health
state: California
city: Santa Rosa
country: United States
facility: Sutter Health
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Snellville
country: United States
facility: Sarah Cannon Research Institute
state: Georgia
city: Overland Park
country: United States
facility: Sarah Cannon Research Institute
state: Kansas
city: Dearborn
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grosse Pointe Farms
country: United States
facility: Henry Ford Health System
state: Michigan
city: Livonia
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Independence
country: United States
facility: Sarah Cannon Research Institute
state: Missouri
city: Avon
country: United States
facility: Cleveland Clinic
state: Ohio
city: Beachwood
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Charleston
country: United States
facility: Sarah Cannon Research Institute
state: South Carolina
city: Hermitage
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: McKinney
country: United States
facility: Sarah Cannon Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: Sarah Cannon Research Institute
state: Utah
city: Richmond
country: United States
facility: Sarah Cannon Research Institute
state: Virginia
city: Richmond
country: United States
facility: Sarah Cannon Research Institute
state: Virginia
city: Salem
country: United States
facility: Sarah Cannon Research Institute
state: Virginia
city: Eau Claire
country: United States
facility: Mayo Clinic
state: Wisconsin
city: La Crosse
country: United States
facility: Mayo Clinic
state: Wisconsin
Study officials:
affiliation: GRAIL, Inc.
name: GRAIL Study Director
role: STUDY_DIRECTOR
References:
citation: Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.