Spots Global Cancer Trial Database for PATHFINDER 2: A Multi-Cancer Early Detection Study
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Trial Identification
Brief Title: PATHFINDER 2: A Multi-Cancer Early Detection Study
Official Title: The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population
Study ID: NCT05155605
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
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, Washington, 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 Township, 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
Texas Oncology - Dallas Presbyterian, Dallas, Texas, United States
Texas Oncology, P.A, Flower Mound, Texas, United States
Texas Oncology, P.A., Fort Worth, 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
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
Contact Details
Name: Justin Chen, MD
Affiliation: GRAIL, LLC
Role: STUDY_DIRECTOR
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