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PATHFINDER 2: a Multi-Cancer Early Detection Study
Sponsor: GRAIL, Inc.
Summary
This is a prospective, multi-center interventional study of the GRAIL multi-cancer early detection (MCED) test with return of test results for participants enrolled through healthcare systems in North America. The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals who are eligible for guideline-recommended cancer screening. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test. 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.
Official title: The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35885
Start Date
2021-12-08
Completion Date
2028-04-30
Last Updated
2024-12-30
Healthy Volunteers
Yes
Conditions
Interventions
Multi-Cancer Early Detection Test
Blood collection and multi-cancer early detection testing with return of results.
Locations (56)
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