Connections: Cancer-detection study seeks enrollees | Spring 2022
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From OHSU Knight Cancer Institute
Tomasz M. Beer, M.D., FACP
Dr. Beer is the deputy director of the Knight Cancer Institute and Pathfinder 2’s principal investigator. He specializes in oncology with a focus in prostate cancer.
“We are optimistic that Pathfinder 2 will continue to solidify the promising results brought forth by the initial Pathfinder study,” Dr. Beer, the study’s principal investigator, said. “Not only will enrollees have the opportunity to gather key information about their own health, they will also help to advance opportunities for early cancer detection across a variety of oncological subtypes.”
Last year, Dr. Tomasz M. Beer, M.D., FACP, deputy director of the Knight Cancer Institute, announced results from Pathfinder, an OHSU-led study that looked into whether a multi-cancer early detection blood test called Galleri™, developed by health care startup Grail, Inc., could accurately detect the presence of cancer in study participants.
Participants were people at least 50 years of age with an elevated cancer risk but no existing indication of active cancer. Along with participants enrolled through OHSU, the study cohort involved participants from six other institutions across the country.
Results of the test, a simple blood draw, were promising — Pathfinder detected a potential 29 cancers among the 6,629 study participants. The test identified more than a dozen types of cancer among the group, including breast, colon, prostate, liver, lymphoid leukemia, lymphoma and Waldenstrom macroglobulinemia, among others. After subsequent diagnostics, 29 participants received a confirmed cancer diagnosis. More than half were in pre-metastatic stages, allowing for earlier intervention and increased survivability rates. Overall, Pathfinder’s accuracy rate was 96.3%.
Now, the Knight Cancer Institute is enrolling patients in Pathfinder 2, the second iteration of the study. This phase will follow an estimated 20,000 participants for approximately three years, beginning on the date they enroll. It will track everything from test results and study-related adverse events to, in cancer-positive enrollees, any necessary treatments and outcomes.
All participants receive one blood draw (40 mL) to initiate the test. They also need to sign an informed consent document, complete a variety of study-related questionnaires and share medical history and records with the study team.
Pathfinder 2 aims to enroll a racially and geographically diverse group of participants, age 50+, from a range of backgrounds. Known elevated risk is not a qualifier. Those undergoing active cancer treatment or diagnostic evaluation for suspected cancer, or those diagnosed with or treated for cancer in the past three years, are not eligible (adjuvant therapy only during the three-year time period is acceptable).
Physicians can recommend Pathfinder 2 to interested patients in their practice who meet eligibility requirements. Potential enrollees can self-refer as well. Enrollment and administration are through either OHSU or a Pathfinder 2 subsite in Bend, Coos Bay or Salem.
Individual study results
Study participants receive results within 30 days of their blood draw, either learning that the test did not detect any malignancies or that they should receive further testing to rule out or confirm the presence of cancer (referring providers convey the test results). When results do show potential cancer, patients visit either OHSU or a partner subsite for diagnostic workups. Patients who ultimately find out that they need treatment can go to a facility of their choice (cancer treatment is not a part of the study).
The Knight Cancer Institute welcomes referrals to the Pathfinder 2 study. Patients interested in joining the study can get more information here. They can also contact a study team member at 503-418-8150 or email@example.com.