Public health researchers at Fred Hutchinson Cancer Center received two new grants to help boost health equity in cancer care and clinical research.
Computational biologist Gavin Ha, PhD, who researches cancer genomics and biomarkers, was awarded a grant from the U.S. Department of Defense to use real-world clinical genomic data to discover new biomarkers that could expand the use of targeted treatments to a wider population of men with prostate cancer. Ha will partner with Memorial Sloan Kettering Cancer Center on the $1 million, three-year project.
Additionally, Jason Mendoza, MD, MPH, professor and director of the Fred Hutch/University of Washington/Seattle Children’s Cancer Consortium’s Office of Community Outreach & Engagement, or OCOE, received a nearly $1 million, two-year grant from Washington State’s Andy Hill CARE Fund to develop and pilot a new program for clinical trial “guides,” in order to boost participation in research studies, especially in underserved populations.
Many of today’s cancer treatments are often determined by sequencing the DNA of tumor cells to look for actionable targets, cancer mutations that can be addressed with newly developed drugs.
Unfortunately, even though this practice is continually growing, the samples of profiled tumors aren’t representative of the full range of patients out there.
“There is still an underrepresentation of tumors profiled for some populations, such as those with African ancestry,” Ha wrote in his grant proposal, explaining that without this data it’s challenging to determine why prostate cancer mortality varies substantially between racial and ancestral backgrounds.
Tumor genomic testing is widely used in the clinic to profile whether mutations exist in a certain panel of genes known to be associated with cancer, Ha said. But these panels usually represent less than 0.2% of the human genome, resulting in missing information that may be crucial to understanding how the tumor may respond to treatment.
With the grant, Ha and collaborator Jian Carrot-Zhang, PhD, at Memorial Sloan Kettering Cancer Center, will analyze over 20,000 tumor samples profiled by DNA sequencing in the real-world clinical setting.
“Our objective is to develop innovative computer algorithms to analyze ancestry markers and DNA alterations throughout the entire genome, beyond the panel of selected genes,” Ha said. “We aim to use these results to unravel the relationship between the DNA alteration patterns and ancestry markers to learn how they contribute to disparities in survival and to discover new biomarkers that predict how prostate cancers respond to treatment.”
Large-scale analysis of clinical sequencing data for more than 20,000 prostate tumors, he said, can address both global ancestry and locus-specific ancestry contributing to prostate cancer genomic differences and outcome disparities.
“The results will have important implications for improving predictive models of disease progression for patients of underrepresented minorities as well as providing insights for biomarker discovery,” he said.
Even better, he believes the tools developed during the project can also be quickly adapted for clinical use.
“This project will also contribute to the ongoing efforts to advance precision oncology for underserved populations,” he said.
Mendoza will partner with several Fred Hutch researchers to create a better system for supporting and enrolling underserved cancer patients onto clinical trials.
Research shows only 8% of cancer patients participate in clinical trials and that participation is lowest in Black, Indigenous and People of Color (BIPOC) populations. Clinician bias, lack of trust (or failure to earn trust), logistics, trial criteria, financial and/or language barriers and many other factors contribute to this lack of enrollment.
Past efforts have focused on educating individual patients as opposed to addressing structural barriers like financial burden, institutional policies and health-related social needs. But recent research by Fred Hutch’s Joe Unger, PhD, has shown structural and clinical barriers keep 3 out of 4 patients from joining a cancer clinical trial.
“Targeting the structural conditions that prevent inclusive participation is key,” Mendoza said. “We need to create an effective structural intervention.”
Toward that end, Mendoza and his team plan to develop and pilot a new program to address health-related social needs and the financial burden of patients who participate in cancer clinical trials.
Their project, dubbed GUIDE, stands for Guiding participation toward Understanding, Inclusion, Diversity, and Equity for Cancer Clinical Trials. The project is based on recent recommendations from the American Society of Clinical Oncology (ASCO) and Association of Community Cancer Centers (ACCC).
— Fred Hutch's Dr. Jason Mendoza, director of the Office of Community Outreach & Engagement
Fred Hutch collaborators include biostatistician Chongzhi Di, PhD; Director of Clinical Research in Hematological Malignancies and Hematology Ajay Gopal, MD, FACP; breast cancer specialist and Associate Director of the Medical Oncology and Hematology Fellowship Program at Fred Hutch and UW Medicine Hannah Linden, MD, FACP, and Evan Ya-Wen Yu, MD, a researcher and medical oncologist who treats patients with prostate, bladder and testicular cancer and who serves as the Clinical Trials Core director of Genitourinary Medical Oncology. Gopal is the medical director of the Protocol Review & Monitoring System for the Cancer Consortium and Linden serves as the co-chair of the Director's Task Force on Inclusion and Equity in Research. Yu is the medical director of the Consortium's Clinical Research Support.
In addition, OCOE staff scientist Jean McDougall, PhD, and Elizabeth Carosso, research project manager, will lead the administrative aspects and day-to-day operations of the study.
“The idea is to use a trained clinical trial staff person, or guide, to act as a liaison between clinicians, patients, trial sponsors, researchers and clinic sites to increase equity from trial conception through dissemination,” Mendoza said.
Each guide will work with research nurses and clinicians to ensure that all patients are screened for available trials; they will also meet with patients who have been pre-screened and offered participation in an available trial. Guides will identify and address health-related social needs and financial barriers to participation; patients who qualify will be reimbursed up to $2,000 for trial participation expenses such as transportation, childcare, food and lodging.
Further, the guides will work with clinical patient navigators to link patients to internal and community resources to address health-related social needs such as food insecurity, transportation, housing instability and utility bills.
Mendoza said the GUIDE program will first be piloted in a 6-month development period in up to four Fred Hutch clinical areas, specifically Breast; Gastrointestinal (GI), which includes colorectal, pancreatic and liver cancers; Genitourinary (GU), which includes bladder, prostate and kidney cancers; and Lymphoma. After that, there will be a 12-month pilot trial that will include up to 100 patients.
“The underrepresentation of marginalized groups in cancer clinical trials poses a serious threat to advancing health equity by limiting access to potentially efficacious treatments and prevention strategies,” Mendoza said.
It also compromises the generalizability of findings and engenders mistrust in clinical research, he said, adding that focusing only on interpersonal and intrapersonal barriers to trial enrollment “hasn’t done much to increase diversity.”
“Convincing patients to enroll in a trial without removing structural and financial barriers is unlikely to result in protocol compliance or participant retention,” he said, pointing to studies that show underrepresented patients are often not offered trial participation or routinely decline participation due to familial responsibilities, financial burden and lack of insurance.
And patients who participate in trials do incur expenses.
One survey of financial burden in patients enrolled in cancer trials found that nearly half of them had out-of-pocket costs of $1,000 or more.
“We need to recognize that at least half of cancer patients would participate in clinical trials if given the opportunity,” Mendoza said. “GUIDE targets the logistical and financial reasons for non-participation. And in doing so, we expect it will improve retention of diverse patients in trials and, ultimately, provide better outcomes for them.”
Diane Mapes is a staff writer at Fred Hutchinson Cancer Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor, she blogs at doublewhammied.com and tweets @double_whammied. Email her at dmapes@fredhutch.org. Just diagnosed and need information and resources? Visit our Patient Care page.
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