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PATHFINDER 2: a Multi-Cancer Early Detection Study
NCT05155605 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DEVICE Multi-Cancer Early Detection Test
Study Locations (20)
California
- Sutter Health — Auburn
- Sutter Health — Davis
- Sutter Health — Elk Grove
- Sutter Health — Fairfield
- HOAG Irvine — Irvine
- HOAG Vivante Newport Mesa — Irvine
- Long Beach Memorial Medical Center — Long Beach
- Sutter Health — Modesto
- HOAG Newport Beach — Newport Beach
- Palo Alto Medical Foundation — Palo Alto
- Sutter Health — Sacramento
- PAMF - Santa Cruz — Santa Cruz
- PAMF - Sunnyvale — Sunnyvale
Louisiana
- Ochsner Grove — Baton Rouge
- Ochsner Lafayette General — Lafayette
Colorado
- Sarah Cannon Research Institute - Englewood Primary Care — Englewood
District of Columbia
- Medstar Washington Hospital Center — Northwest
Florida
- Woodlands Medical Specialists — Pensacola
Georgia
- Morehouse School of Medicine — Atlanta
Illinois
- University of Illinois at Chicago — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35,885 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2028-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05155605
The ClinicalTrials.gov registry entry for NCT05155605 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35,885 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GRAIL, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention — of which Multi-Cancer Early Detection Test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05155605 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Louisiana, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05155605 about?
NCT05155605 is a clinical study titled "PATHFINDER 2: a Multi-Cancer Early Detection Study". 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...
What is the current status of trial NCT05155605?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 35,885 participants. The study started on 2021-12-08. Estimated completion is 2028-04-30.
What conditions does trial NCT05155605 study?
This clinical trial studies the following conditions: Cancer, Early Detection of Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05155605?
The interventions under investigation include: Multi-Cancer Early Detection Test (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05155605?
This trial is sponsored by GRAIL, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05155605 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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