COLUMBUS, Ohio – The Center for Personalized Health Care at The Ohio State University Medical Center, along with one of the most prestigious and leading biomedical research institutions in the world, is using an integrated approach to recruiting study participants for a personalized genomics study focusing on the effect genetic counseling related to personal genomic test results has on patients with chronic disease.
Ohio State Medical Center and the Coriell Institute for Medical Research, home of the world’s leading biobank resource for human cells and DNA, are enrolling 1,800 patients at the Medical Center into the Coriell Personalized Medicine Collaborative (CPMC). Those enrolled will constitute the largest randomized research project of the CPMC, to date, looking at how genetic counseling impacts how patients respond to personal risk information for diseases, such as melanoma and age-related macular degeneration. Ohio State is the first institution to involve physicians and their patients with heart disease or hypertension in the process.
“Partnerships like the CPMC reinforce OSU Medical Center’s commitment to improving people’s lives through personalized health care,” says Dr. Steven Gabbe, Medical Center CEO. “When we can engage patients in their own health transformation, it is a tremendous help in providing them a higher quality of care and improving the cost-effectiveness of our outcomes.”
Study investigators are targeting two specific groups of patients. Physicians from Ohio State’s Ross Heart Hospital are recruiting up to 900 patients diagnosed with congestive heart failure (CHF), and OSU internal medicine physicians will recruit 900 patients with hypertension, commonly known as high blood pressure.
“We hope to show the benefit of genetic counseling on these particular patients,” says Kevin Sweet, a genetic counselor and co-investigator of the study at Ohio State. “We want to know if consistent support and follow through affect patients’ willingness to initiate lifestyle change(s) and whether a better understanding of disease risk and utilization of risk reports prompts ongoing communication with their physician.”
“Another very important goal of the study is to educate physicians on the use of genomic information and implementing genetic counseling in everyday clinical practice,” says Dr. Clay Marsh, executive director of Ohio State’s Center for Personalized Health Care.
According to Marsh, the goal is to engage patients to become more actively involved in their own healthcare management. “Overall, we want to improve people’s lives through health care that is predictive, preventive, personalized and participatory,” he adds.
Some patients with CHF respond differently to heart failure medications. Investigators also want to study whether genetic data is effective at differentiating patients with CHF who respond to treatment compared to CHF patients who are non- responders to a standard treatment regimen. In addition, investigators want to find out whether genetic data are effective at predicting which newly diagnosed patients with high blood pressure will require adjustments to medications.
“We hope to identify unique genetic signatures between these two groups. We may also find gene variants, or single nucleotide polymorphisms (SNPs), associated with common drugs used in these patients that may help with managing individual treatment,” Sweet says.
In addition to the on-going patient-based chronic disease study, Ohio State researchers are enrolling 200 volunteers from the central Ohio area into the CPMC, free of charge. The CPMC is a unique personalized medicine study, in that it not only takes into account genetic variants, but also each individual’s family history and important non-genetic risk factors such as smoking, body mass index, environmental factors, diet, exercise and lifestyle to develop personalized risk reports. Researchers expect this study to last at least 10 years.
Saliva samples will be obtained from each participant and sent to Coriell for DNA testing using microarrays to examine approximately 2 million SNPs. This analysis will help determine one part of an individual’s genetic risk for a number of common diseases such as age-related macular degeneration, colon cancer, coronary artery disease, melanoma, and type 1 and type 2 diabetes. Investigators will also be looking at select gene variants for response to certain medications including Coumadin, a common drug used to treat people with blood clots. In addition, researchers hope to find presently unknown SNPs that may elevate one’s risk of complex disease or affect an individual’s response to medications.
“We really want to find out if this type of information will be useful to the average person. Will it improve and personalize their health care over time?” says Sweet.
OSU Medical Center is one of only five centers in the country participating in CPMC project(s) with Coriell. Other participants are being enrolled at Fox Chase Cancer Center, Cooper University Hospital and Virtua Health. Study participants also include volunteers from the Camden, N.J. community, where Coriell is headquartered.
Along with Marsh and Sweet, other Ohio State researchers involved in the studies are, Amy Sturm, Kandamurugu Manickam, Philip Binkley, Wolfgang Sadee, Marialice Bennett, Linda Strout, Amanda Toland, Meagan Kane and Henry Zheng. The study co-investigators from Coriell are Michael Christman, Margaret Keller, Erynn Gordon and Cathy Stack.
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