PATHFINDER 2: a Multi-Cancer Early Detection Study

Last updated: December 24, 2024
Sponsor: GRAIL, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer

Treatment

Multi-Cancer Early Detection Test

Clinical Study ID

NCT05155605
GRAIL-012
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be at least 50 years of age, inclusive, at the time of signing theInformed Consent Form (ICF).

  2. Participants must be capable of giving signed and legally effective informed consent

Exclusion

Exclusion Criteria:

  1. Undergoing or referred for diagnostic evaluation due to clinical suspicion forcancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsyon the basis of a suspicious imaging abnormality).

  2. Personal history of invasive solid tumor or hematologic malignancy, diagnosed withinthe 3 years prior to expected enrollment date, or diagnosed greater than 3 yearsprior to expected enrollment date and never treated.

  • Individuals with a diagnosis of non-metastatic basal cell carcinoma andsquamous cell carcinoma of the skin are not excluded.
  1. Prior/Concurrent Concomitant Therapy (Medications/Treatments):
  • Definitive treatment for invasive solid tumor or hematologic malignancy withinthe 3 years prior to expected enrollment date. Adjuvant hormone therapy forcancer (e.g. for breast or prostate cancer) is not an exclusion criterion.
  1. Individuals who will not be able to comply with the protocol procedures.

  2. Individuals who are not currently registered patients at a participating center.

  3. Previous or current participation in another GRAIL-sponsored study. "Participation"is defined as having signed consent and provided a blood sample.

  4. Previous or current employees or contractors of GRAIL.

  5. Current pregnancy (by self-report of pregnancy status)

Study Design

Total Participants: 35885
Treatment Group(s): 1
Primary Treatment: Multi-Cancer Early Detection Test
Phase:
Study Start date:
December 08, 2021
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • University Health Network

    Toronto, Ontario M5G 2C1
    Canada

    Site Not Available

  • Sutter Health

    Auburn, California 95602
    United States

    Site Not Available

  • Sutter Health

    Davis, California 95616
    United States

    Site Not Available

  • Sutter Health

    Elk Grove, California 95758
    United States

    Site Not Available

  • Sutter Health

    Fairfield, California 94534
    United States

    Site Not Available

  • HOAG Irvine

    Irvine, California 92663
    United States

    Site Not Available

  • HOAG Vivante Newport Mesa

    Irvine, California 92663
    United States

    Site Not Available

  • Long Beach Memorial Medical Center

    Long Beach, California 90806
    United States

    Site Not Available

  • Sutter Health

    Modesto, California 95355
    United States

    Site Not Available

  • HOAG Newport Beach

    Newport Beach, California 92663
    United States

    Site Not Available

  • Palo Alto Medical Foundation

    Palo Alto, California 94301
    United States

    Site Not Available

  • Sutter Health

    Roseville, California 95661
    United States

    Site Not Available

  • Sutter Health

    Sacramento, California 95816
    United States

    Site Not Available

  • PAMF - Santa Cruz

    Santa Cruz, California 95062
    United States

    Site Not Available

  • PAMF - Sunnyvale

    Sunnyvale, California 94086
    United States

    Site Not Available

  • Sarah Cannon Research Institute - Englewood Primary Care

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    NW, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Woodlands Medical Specialists

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Morehouse School of Medicine

    Atlanta, Georgia 30310
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60608
    United States

    Site Not Available

  • Ochsner Grove

    Baton Rouge, Louisiana 70836
    United States

    Site Not Available

  • Ochsner Lafayette General

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • Ochsner Health

    New Orleans, Louisiana 70127
    United States

    Site Not Available

  • Maryland Oncology Hematology

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Henry Ford Macomb

    Clinton, Michigan 48038
    United States

    Site Not Available

  • Henry Ford Macomb

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • Henry Ford Medical Center Ford Road

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Medical Center Detroit North West

    Detroit, Michigan 48235
    United States

    Site Not Available

  • Henry Ford Medical Center Harbortown

    Detroit, Michigan 48207
    United States

    Site Not Available

  • Henry Ford Medical Center Sterling Heights

    Sterling Heights, Michigan 48310
    United States

    Site Not Available

  • Mayo Clinic - Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

  • Flushing Hospital Medical Center

    Queens, New York 11355
    United States

    Site Not Available

  • Jamaica Hospital Medical Center

    Queens, New York 11418
    United States

    Site Not Available

  • Sarah Cannon Asheville Family Medicine

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Duke University Health System

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • St. Charles Health System

    Bend, Oregon 97701
    United States

    Site Not Available

  • Oregon Health & Science University Bay Area Hospital

    Coos Bay, Oregon 97420
    United States

    Site Not Available

  • Oregon Health & Science University Knight Cancer Institute

    Portland, Oregon 97201
    United States

    Site Not Available

  • SALEM Health

    Salem, Oregon 97301
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Sarah Cannon Research Institute - The Frist Clinic

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon, Centennial Internal Medicine Continuity Clinic

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Oncology - West Texas

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Sarah Cannon, Austin Diagnostic Clinic

    Austin, Texas 78758
    United States

    Site Not Available

  • Texas Oncology - Dallas Presbyterian

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Oncology - Flower Mound

    Flower Mound, Texas 75028
    United States

    Site Not Available

  • Texas Oncology, P.A

    Flower Mound, Texas 75028
    United States

    Site Not Available

  • Texas Oncology - Fort Worth

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Oncology, P.A.

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Kelsey-Seybold Clinic Cypress Woods

    Houston, Texas 77014
    United States

    Site Not Available

  • Kelsey-Seybold Clinic Holcombe

    Houston, Texas 77025
    United States

    Site Not Available

  • Texas Oncology - Plano East

    Plano, Texas 75075
    United States

    Site Not Available

  • Texas Oncology - Plano West

    Plano, Texas 75093
    United States

    Site Not Available

  • University Texas Health San Antonio - Mays Cancer Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Oncology - Tyler

    Tyler, Texas 75702
    United States

    Site Not Available

  • Inova

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Eastern Virginia Medical School

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Northwest, Washington 20010
    United States

    Site Not Available

  • Northwest Cancer Specialists

    Vancouver, Washington 98684
    United States

    Site Not Available

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