๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-11

PATHFINDER 2: A Multi-Cancer Early Detection Study (NCT05155605)

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

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: GRAIL, Inc.

๐Ÿฉบ 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: Review the eligibility criteria below.

Location: Sutter Health โ€” Auburn, California

Age range: 50 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (56 Sites)

Showing the first 25 of 56 sites.

  • Sutter Health โ€” Auburn, California
  • Sutter Health โ€” Davis, California
  • Sutter Health โ€” Elk Grove, California
  • Sutter Health โ€” Fairfield, California
  • HOAG Irvine โ€” Irvine, California
  • HOAG Vivante Newport Mesa โ€” Irvine, California
  • Long Beach Memorial Medical Center โ€” Long Beach, California
  • Sutter Health โ€” Modesto, California
  • HOAG Newport Beach โ€” Newport Beach, California
  • Palo Alto Medical Foundation โ€” Palo Alto, California
  • Sutter Health โ€” Sacramento, California
  • PAMF - Santa Cruz โ€” Santa Cruz, California
  • PAMF - Sunnyvale โ€” Sunnyvale, California
  • Sarah Cannon Research Institute - Englewood Primary Care โ€” Englewood, Colorado
  • Medstar Washington Hospital Center โ€” Northwest, District of Columbia
  • Woodlands Medical Specialists โ€” Pensacola, Florida
  • Morehouse School of Medicine โ€” Atlanta, Georgia
  • University of Illinois at Chicago โ€” Chicago, Illinois
  • Ochsner Grove โ€” Baton Rouge, Louisiana
  • Ochsner Lafayette General โ€” Lafayette, Louisiana
  • Ochsner Health โ€” New Orleans, Louisiana
  • Maryland Oncology Hematology โ€” Annapolis, Maryland
  • Henry Ford Macomb โ€” Clinton, Michigan
  • Henry Ford Medical Center Ford Road โ€” Dearborn, Michigan
  • Henry Ford Health System โ€” Detroit, Michigan

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—