PATHFINDER 2: A Multi-Cancer Early Detection Study

NCT05155605 | Active Not Recruiting DMC FDA Device

• 1 other identifier: GRAIL-012
• Study Type: interventional
• Target: 35,885
• Locations: 2 countries
• Sites: 56

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.

Conditions

Early Detection of Cancer; Cancer

Keywords

multi-cancer early detection; cancer screening; circulating cell-free tumor DNA; MCED

Outcome Measures

Primary Outcomes (8)

• Safety: Number and type of invasive procedures performed in participants with a cancer signal detected by the multi-cancer early detection (MCED) test and no cancer diagnosis at the time of diagnostic resolution (i.e., false positive test result).

  Up to 3 Years

• Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).

  Up to 3 Years

• Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).

  Up to 3 Years

• Test performance: diagnosis of invasive cancer, assessed by sensitivity.

  Up to 3 Years

• Test performance: diagnosis of invasive cancer, assessed by specificity.

  Up to 3 Years

• Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.

  Up to 3 Years

• Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR).

  Up to 3 Years

• Test performance: diagnosis of invasive cancer, assessed by number needed to screen to detect an invasive cancer (NNS).

  Up to 3 Years

Secondary Outcomes (7)

• Participant-reported anxiety resulting from use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.

  Up to 3 Years

• Participant-reported intention to follow and use guideline recommended cancer screening procedures after use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.

  Up to 3 Years

• Cancer detection rate of confirmatory PET-CT in participants for whom cancer signal origin directed workups do not result in diagnosis of cancer.

  Up to 3 Years

• Number and type of diagnostic evaluations (imaging procedures, invasive procedures, laboratory test) by predicted cancer signal origin and outcome of diagnostic resolution.

  Up to 3 Years

• Per-participant radiation exposure during diagnostic evaluation for test positive participants.

  Up to 3 Years

Study Arms (1)

Participants 50 years of age or older

EXPERIMENTAL

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.

Device: Multi-Cancer Early Detection Test

Interventions

Multi-Cancer Early Detection Test DEVICE

Blood collection and multi-cancer early detection testing with return of results.

Participants 50 years of age or older

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be at least 50 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
• Participants must be capable of giving signed and legally effective informed consent

You may not qualify if:

• Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
• 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.
• Prior/Concurrent Concomitant Therapy (Medications/Treatments):
• Individuals who will not be able to comply with the protocol procedures.
• Individuals who are not currently registered patients at a participating center.
• Previous or current participation in another GRAIL-sponsored study. "Participation" is defined as having signed consent and provided a blood sample.
• Previous or current employees or contractors of GRAIL.
• Current pregnancy (by self-report of pregnancy status)

Sponsors & Collaborators

• GRAIL, Inc.: lead

Study Sites (56)

Sutter Health

Auburn, California, 95602, United States

Location

Sutter Health

Davis, California, 95616, United States

Location

Sutter Health

Elk Grove, California, 95758, United States

Location

Sutter Health

Fairfield, California, 94534, United States

Location

HOAG Irvine

Irvine, California, 92663, United States

Location

HOAG Vivante Newport Mesa

Irvine, California, 92663, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Sutter Health

Modesto, California, 95355, United States

Location

HOAG Newport Beach

Newport Beach, California, 92663, United States

Location

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Sutter Health

Sacramento, California, 95816, United States

Location

PAMF - Santa Cruz

Santa Cruz, California, 95062, United States

Location

PAMF - Sunnyvale

Sunnyvale, California, 94086, United States

Location

Sarah Cannon Research Institute - Englewood Primary Care

Englewood, Colorado, 80113, United States

Location

Medstar Washington Hospital Center

Northwest, District of Columbia, 20010, United States

Location

Woodlands Medical Specialists

Pensacola, Florida, 32503, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Ochsner Grove

Baton Rouge, Louisiana, 70836, United States

Location

Ochsner Lafayette General

Lafayette, Louisiana, 70503, United States

Location

Ochsner Health

New Orleans, Louisiana, 70127, United States

Location

Maryland Oncology Hematology

Annapolis, Maryland, 21401, United States

Location

Henry Ford Macomb

Clinton, Michigan, 48038, United States

Location

Henry Ford Medical Center Ford Road

Dearborn, Michigan, 48126, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Henry Ford Medical Center Harbortown

Detroit, Michigan, 48207, United States

Location

Henry Ford Medical Center Detroit North West

Detroit, Michigan, 48235, United States

Location

Henry Ford Medical Center Sterling Heights

Sterling Heights, Michigan, 48310, United States

Location

Mayo Clinic - Cancer Center

Rochester, Minnesota, 55905, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Flushing Hospital Medical Center

Queens, New York, 11355, United States

Location

Jamaica Hospital Medical Center

Queens, New York, 11418, United States

Location

Sarah Cannon Asheville Family Medicine

Asheville, North Carolina, 28801, United States

Location

Duke University Health System

Durham, North Carolina, 27705, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

St. Charles Health System

Bend, Oregon, 97701, United States

Location

Oregon Health & Science University Bay Area Hospital

Coos Bay, Oregon, 97420, United States

Location

Oregon Health & Science University Knight Cancer Institute

Portland, Oregon, 97201, United States

Location

SALEM Health

Salem, Oregon, 97301, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Sarah Cannon Research Institute - The Frist Clinic

Nashville, Tennessee, 37203, United States

Location

Sarah Cannon, Centennial Internal Medicine Continuity Clinic

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - West Texas

Amarillo, Texas, 79106, United States

Location

Sarah Cannon, Austin Diagnostic Clinic

Austin, Texas, 78758, United States

Location

Kelsey-Seybold Clinic Cypress Woods

Houston, Texas, 77014, United States

Location

Kelsey-Seybold Clinic Holcombe

Houston, Texas, 77025, United States

Location

Texas Oncology - Plano East

Plano, Texas, 75075, United States

Location

Texas Oncology - Plano West

Plano, Texas, 75093, United States

Location

University Texas Health San Antonio - Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Inova

Fairfax, Virginia, 22031, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Northwest Cancer Specialists

Vancouver, Washington, 98684, United States

Location

University Health Network

Toronto, Ontario, M5G 2C1, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Celine Marquez, MD

  GRAIL, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 13, 2021
• Study Start: December 8, 2021
• Primary Completion: February 11, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (55)