The University of Illinois Chicago (UIC) will participate in a national study of a clinical test that screens for a shared cancer signal in a sample of patient blood. Beginning this fall, the University of Illinois Cancer Center and the UI Health Mile Square Health Center will enroll patients 50 years and older of average health in the PATHFINDER 2 trial led by the biotechnology company GRAIL.
The Cancer Center brings to the study a diverse patient population where nearly four out of five participants in clinical trials come from underrepresented groups, according to the university. The trial also offers patients at Mile Square, a federally qualified health center providing primary care to underserved populations, the opportunity for screening with this new multi-cancer detection technology.
“We are giving economically vulnerable racial and ethnic minorities access to cutting-edge diagnostics that they wouldn’t have access to otherwise,” says Darlene Kitterman, director of clinical trials at the Cancer Center.
The trial will assess GRAIL’s Galleri blood test, which screens for a cancer signal shared by more than 50 types of cancers. Many of these diseases, such as pancreatic and blood cancers, do not currently have recommended screening tests and often go undetected until later stages when they start causing severe symptoms and may be harder to treat.
“Cancer cells are inherently fragile and constantly turning over,” says VK Gadi, MD, PhD, deputy director of the Cancer Center and professor of hematology and oncology at UIC. “As part of that process, they spill their contents, including DNA, into the bloodstream. If we see this pattern, we may be able to say it’s associated with cancer and even specifically say where that cancer might be coming from in the body.”
While the test is commercially available, it has yet to receive approval from the Food and Drug Administration and the Centers for Medicare and Medicaid Services. The study will evaluate the performance and safety of the test at dozens of clinical sites across the United States.
GRAIL Galleri Blood Test Trial
Participants in the trial will have blood drawn during a primary care visit and receive test results within 14 days. If a positive signal is detected, the patient will receive follow-up diagnostic tests, such as a CT scan or endoscopy, to confirm whether a cancer is present.
Among the institutions participating in the trial, UIC is well-suited to assess how the test performs in the patients most often covered by federal health insurance, according to a release.
“We are a rare academic medical center that accepts all Medicaid contracts, in addition to comprehensive charity care for uninsured and uninsurable patients,” says Yamilé Molina, PhD, associate professor of community health sciences, associate director for community outreach and engagement at the Cancer Center and associate director for community engaged research at Mile Square Health Center. “We are going to be recruiting from the patient base of Medicare and Medicaid, and we’re going to see how well it works in these populations.”
The PATHFINDER 2 study will be the first partnership between the Cancer Center and Mile Square to recruit patients for an industry-sponsored trial across the health center’s seven locations in Chicago, Cicero and Rockford. But the institutions previously have collaborated on cancer prevention studies and patient care, including the establishment of the first genetic counseling and testing program at a federally qualified health center.
“This is groundbreaking research, and we are proud that Mile Square has the opportunity to participate with the University of Illinois Cancer Center,” says Henry Taylor, president and chief executive officer of Mile Square Health Center. “We are pleased that communities of color have the opportunity to be a part of this transformative research.”
Participating in the study reflects the community-focused mission of the University of Illinois Cancer Center, which offers 244 open clinical trials to the diverse patients seen at UI Health and associated clinics. Enrollment in the UIC site of PATHFINDER 2 is expected to begin in late October.
“We are constructing what we think is going to be a national model to make sure that health care and cancer innovation reaches everybody in our communities,” Gadi says. “We have built a framework that we hope is reproducible for others, if they want to genuinely reach these communities.”
Featured image: UI Health Mile Square Health Center at Wood and Roosevelt streets. Photo: Hoss Fatemi/UI Health