PATHFINDER 2: A Multi-Cancer Early Detection Study (NCT05155605)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (11 items).
Location: Sutter Health — Auburn, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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):
- Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (56 Sites)
- Sutter Health — Auburn, California
- Sutter Health — Davis, California
- Sutter Health — Elk Grove, California
- Sutter Health — Fairfield, California
- HOAG Irvine — Irvine, California
- HOAG Vivante Newport Mesa — Irvine, California
- Long Beach Memorial Medical Center — Long Beach, California
- Sutter Health — Modesto, California
- HOAG Newport Beach — Newport Beach, California
- Palo Alto Medical Foundation — Palo Alto, California
- Sutter Health — Sacramento, California
- PAMF - Santa Cruz — Santa Cruz, California
- PAMF - Sunnyvale — Sunnyvale, California
- Sarah Cannon Research Institute - Englewood Primary Care — Englewood, Colorado
- Medstar Washington Hospital Center — Northwest, District of Columbia
- Woodlands Medical Specialists — Pensacola, Florida
- Morehouse School of Medicine — Atlanta, Georgia
- University of Illinois at Chicago — Chicago, Illinois
- Ochsner Grove — Baton Rouge, Louisiana
- Ochsner Lafayette General — Lafayette, Louisiana
- Ochsner Health — New Orleans, Louisiana
- Maryland Oncology Hematology — Annapolis, Maryland
- Henry Ford Macomb — Clinton, Michigan
- Henry Ford Medical Center Ford Road — Dearborn, Michigan
- Henry Ford Health System — Detroit, Michigan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.