Pathfinder 2

The Problem

Today, cancer is a leading cause of death worldwide. That’s in large part because there is no screening available for the vast majority of life-threatening cancers, and as a result, most cancers are detected too late when outcomes are often fatal.

Guideline-recommended screening tests save lives, but they cover just five cancers, and each one screens for a single cancer at a time. Cancers responsible for approximately two-thirds of cancer deaths have no recommended early detection screening.

The Solution

The DCI Center for Onco-Primary Care and Duke Primary Care clinics are partnering with Grail, LLC in the Pathfinder 2 study. This is a prospective, multi-center interventional study of the Galleri multi-cancer early detection test with the 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 Galleri test in a population of individuals aged 50 years and older who are not actively being evaluated or treated for cancer. Participants with a “cancer signal detected” test result will receive targeted diagnostic procedures based on the predicted cancer signal origin(s) to determine if cancer is present. The number and types of diagnostic procedures needed to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess perceptions about the multi-cancer early detection test.

The study will enroll approximately 20,000 eligible participants over an anticipated enrollment period of approximately 18 months at clinical institutions within North America. Participants will be actively followed for approximately 3 years.

Site Principal Investigator: Kevin Oeffinger, MD
Site Sub-Investigator: Ranee Chatterjee Montgomery, MD, MPH

The Goal

At Duke Cancer Institute, we will be enrolling 1,000 patients who receive care at one of our participating Duke Primary Care Clinics (Duke Primary Care Arringdon, Duke Primary Care Brier Creek, Duke Primary Care Croasdaile, Duke Primary Care Mebane, Duke Primary Care Pickett Rd, Duke Primary Care Riverview, Duke Primary Care South Durham, Duke Primary Care Waverly Place), the Duke Family Medicine Center (Pickens Building, Durham), the High-Risk Breast Clinic, and through our Survivorship Clinic at the Duke Cancer Center in Durham. Study visits will be done at the Duke Cancer Center in Durham or at Duke Research at Pickett Road.

Participants only qualify if they are not on active cancer treatment, do not have chronic cancer, are a minimum of three years out from cancer diagnosis, and are over 50. The study does cover all costs associated with testing and specialty visits.