Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
35885 participants
INTERVENTIONAL
2021-12-08
2028-04-30
Brief Summary
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The study will enroll approximately 35,000 and no more than 38,500 participants as defined by eligibility criteria over an anticipated enrollment period of approximately 36 months at up to 40 clinical institutions within North America. Participants will be actively followed for approximately 3 years from the date of their enrollment.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Participants 50 years of age or older
The study will aim to enroll a diverse participant population generally representative of the US population with respect to race, ethnicity, and sex. The target age categories of 60-69 years and 70-79 years will be enriched to increase the number of cancer events that are observed during the study.
Multi-Cancer Early Detection Test
Blood collection and multi-cancer early detection testing with return of results.
Interventions
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Multi-Cancer Early Detection Test
Blood collection and multi-cancer early detection testing with return of results.
Eligibility Criteria
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Inclusion Criteria
2. Participants must be capable of giving signed and legally effective informed consent
Exclusion Criteria
2. Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated.
* Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
3. Prior/Concurrent Concomitant Therapy (Medications/Treatments):
* Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.
4. Individuals who will not be able to comply with the protocol procedures.
5. Individuals who are not currently registered patients at a participating center.
6. Previous or current participation in another GRAIL-sponsored study. "Participation" is defined as having signed consent and provided a blood sample.
7. Previous or current employees or contractors of GRAIL.
8. Current pregnancy (by self-report of pregnancy status)
50 Years
ALL
Yes
Sponsors
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GRAIL, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Celine Marquez, MD
Role: STUDY_DIRECTOR
GRAIL, Inc.
Locations
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Sutter Health
Auburn, California, United States
Sutter Health
Davis, California, United States
Sutter Health
Elk Grove, California, United States
Sutter Health
Fairfield, California, United States
HOAG Irvine
Irvine, California, United States
HOAG Vivante Newport Mesa
Irvine, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Sutter Health
Modesto, California, United States
HOAG Newport Beach
Newport Beach, California, United States
Palo Alto Medical Foundation
Palo Alto, California, United States
Sutter Health
Sacramento, California, United States
PAMF - Santa Cruz
Santa Cruz, California, United States
PAMF - Sunnyvale
Sunnyvale, California, United States
Sarah Cannon Research Institute - Englewood Primary Care
Englewood, Colorado, United States
Medstar Washington Hospital Center
Northwest, District of Columbia, United States
Woodlands Medical Specialists
Pensacola, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Ochsner Grove
Baton Rouge, Louisiana, United States
Ochsner Lafayette General
Lafayette, Louisiana, United States
Ochsner Health
New Orleans, Louisiana, United States
Maryland Oncology Hematology
Annapolis, Maryland, United States
Henry Ford Macomb
Clinton, Michigan, United States
Henry Ford Medical Center Ford Road
Dearborn, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Henry Ford Medical Center Harbortown
Detroit, Michigan, United States
Henry Ford Medical Center Detroit North West
Detroit, Michigan, United States
Henry Ford Medical Center Sterling Heights
Sterling Heights, Michigan, United States
Mayo Clinic - Cancer Center
Rochester, Minnesota, United States
Weill Cornell Medicine
New York, New York, United States
Flushing Hospital Medical Center
Queens, New York, United States
Jamaica Hospital Medical Center
Queens, New York, United States
Sarah Cannon Asheville Family Medicine
Asheville, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
St. Charles Health System
Bend, Oregon, United States
Oregon Health & Science University Bay Area Hospital
Coos Bay, Oregon, United States
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, United States
SALEM Health
Salem, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute - The Frist Clinic
Nashville, Tennessee, United States
Sarah Cannon, Centennial Internal Medicine Continuity Clinic
Nashville, Tennessee, United States
Texas Oncology - West Texas
Amarillo, Texas, United States
Sarah Cannon, Austin Diagnostic Clinic
Austin, Texas, United States
Kelsey-Seybold Clinic Cypress Woods
Houston, Texas, United States
Kelsey-Seybold Clinic Holcombe
Houston, Texas, United States
Texas Oncology - Plano East
Plano, Texas, United States
Texas Oncology - Plano West
Plano, Texas, United States
University Texas Health San Antonio - Mays Cancer Center
San Antonio, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Inova
Fairfax, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
University Health Network
Toronto, Ontario, Canada
Countries
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Other Identifiers
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GRAIL-012
Identifier Type: -
Identifier Source: org_study_id