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Active, not recruiting Not applicable Interventional Accepts healthy volunteers

PATHFINDER 2: A Multi-Cancer Early Detection Study

ClinicalTrials.gov ID: NCT05155605

Public ClinicalTrials.gov record NCT05155605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05155605
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
GRAIL, Inc.
Industry
Enrollment
35,883 participants

Conditions and interventions

Eligibility (public fields only)

Age range
50 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 8, 2021 (Actual)
Primary completion
Feb 11, 2026 (Actual)
Completion
Apr 30, 2028 (Estimated)
Last update posted
May 14, 2026

2021 – 2028

United States locations

U.S. sites
55
U.S. states
20
U.S. cities
48
Facility City State ZIP Site status
Sutter Health Auburn California 95602 —
Sutter Health Davis California 95616 —
Sutter Health Elk Grove California 95758 —
Sutter Health Fairfield California 94534 —
HOAG Irvine Irvine California 92663 —
HOAG Vivante Newport Mesa Irvine California 92663 —
Long Beach Memorial Medical Center Long Beach California 90806 —
Sutter Health Modesto California 95355 —
HOAG Newport Beach Newport Beach California 92663 —
Palo Alto Medical Foundation Palo Alto California 94301 —
Sutter Health Sacramento California 95816 —
PAMF - Santa Cruz Santa Cruz California 95062 —
PAMF - Sunnyvale Sunnyvale California 94086 —
Sarah Cannon Research Institute - Englewood Primary Care Englewood Colorado 80113 —
Medstar Washington Hospital Center Northwest District of Columbia 20010 —
Woodlands Medical Specialists Pensacola Florida 32503 —
Morehouse School of Medicine Atlanta Georgia 30310 —
University of Illinois at Chicago Chicago Illinois 60608 —
Ochsner Grove Baton Rouge Louisiana 70836 —
Ochsner Lafayette General Lafayette Louisiana 70503 —
Ochsner Health New Orleans Louisiana 70127 —
Maryland Oncology Hematology Annapolis Maryland 21401 —
Henry Ford Macomb Clinton Michigan 48038 —
Henry Ford Medical Center Ford Road Dearborn Michigan 48126 —
Henry Ford Health System Detroit Michigan 48202 —
Henry Ford Medical Center Harbortown Detroit Michigan 48207 —
Henry Ford Medical Center Detroit North West Detroit Michigan 48235 —
Henry Ford Medical Center Sterling Heights Sterling Heights Michigan 48310 —
Mayo Clinic - Cancer Center Rochester Minnesota 55905 —
Weill Cornell Medicine New York New York 10065 —
Flushing Hospital Medical Center Queens New York 11355 —
Jamaica Hospital Medical Center Queens New York 11418 —
Sarah Cannon Asheville Family Medicine Asheville North Carolina 28801 —
Duke University Health System Durham North Carolina 27705 —
Cleveland Clinic Cleveland Ohio 44195 —
University of Oklahoma Oklahoma City Oklahoma 73104 —
St. Charles Health System Bend Oregon 97701 —
Oregon Health & Science University Bay Area Hospital Coos Bay Oregon 97420 —
Oregon Health & Science University Knight Cancer Institute Portland Oregon 97201 —
SALEM Health Salem Oregon 97301 —
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213 —
Sarah Cannon Research Institute - The Frist Clinic Nashville Tennessee 37203 —
Sarah Cannon, Centennial Internal Medicine Continuity Clinic Nashville Tennessee 37203 —
Texas Oncology - West Texas Amarillo Texas 79106 —
Sarah Cannon, Austin Diagnostic Clinic Austin Texas 78758 —
Kelsey-Seybold Clinic Cypress Woods Houston Texas 77014 —
Kelsey-Seybold Clinic Holcombe Houston Texas 77025 —
Texas Oncology - Plano East Plano Texas 75075 —
Texas Oncology - Plano West Plano Texas 75093 —
University Texas Health San Antonio - Mays Cancer Center San Antonio Texas 78229 —
Texas Oncology - Tyler Tyler Texas 75702 —
Inova Fairfax Virginia 22031 —
Eastern Virginia Medical School Norfolk Virginia 23510 —
Virginia Commonwealth University Richmond Virginia 23219 —
Northwest Cancer Specialists Vancouver Washington 98684 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05155605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 14, 2026 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05155605 live on ClinicalTrials.gov.

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