NorthShore launches first clinical trial to examine GRS test for cancer risk assessment

Researchers at NorthShore University HealthSystem (NorthShore) have launched the first clinical trial to investigate a genetic risk score (GRS) test to predict the risk of breast, prostate and colorectal cancer in the primary care setting. The test was developed by NorthShore researcher Jianfeng Xu, DrPH, in order to provide primary care physicians with a tool to better understand how to prevent and treat cancer, and learn how patients respond after learning of increased cancer risk. The outcome of the clinical trial will inform the integration of the genetic risk score test into practice by the health system's approximately 150 primary care physicians.

While evaluating patients' responses to finding out their genetic risk score for breast, colorectal and prostate cancer, the trial also examines whether patients with results that indicate increased cancer risk adhere to NorthShore's modified cancer screening guidelines. For those with an elevated cancer risk, a more intensive cancer screening plan would be discussed.

"The goal of the study is to evaluate several practical aspects of implementing genomic information for personalized care. Using our genetic risk assessment, patients will better understand their own individual risk for developing certain cancers," said Dr. Xu, who is Vice President of Translational Research at NorthShore and Director of the Program for Personalized Cancer Care. "They will undergo screening when necessary, appropriately narrowing or expanding their scope of medical care. This is an important part of what makes personalized care at NorthShore unique: that is, offering genomic-based targeted care from prevention, to screening, to diagnosis and treatment of early and late-stage disease."

Dr. Xu has utilized his 20 years of genomic research experience to lead the test development, which provides a numeric risk score for patients regardless of family history.

"Genetic information can be a powerful tool in understanding risk and recommending earlier screenings, especially when utilized at patients' main access points to healthcare -- primary care physicians," said Peter Hulick, MD, Medical Director for NorthShore's Center for Personalized Medicine. "While family history often informs screening guidelines for cancer, many patients are either unaware of family history or develop diseases despite a lack of history. It's integral to the success of NorthShore and our patients that their physicians use genetic information accurately, appropriately and early in the process."

The clinical trial will enroll 500 consenting patients who submitted blood samples through NorthShore's Genomic Health Initiative, a research program aiming to collect a large number of blood samples to better compare genomic information across a variety of health conditions to improve the prevention and treatment of diseases on a larger scale. Participants in the clinical trial are between 40 and 70 years of age with no prior diagnosis of colorectal, breast or prostate cancer. Results are expected in about one year.

NorthShore is taking this proactive, preventive approach to healthcare with the intent to make a genetic risk score test available to all interested NorthShore patients in the future. The test will ultimately include a wider array of cancers and other diseases, as well.

In addition, NorthShore envisions using the genetic risk score to improve the effectiveness of how patients are treated. "In the next phase of the test, some patients with early cancer, especially those with prostate cancer, will not need aggressive treatment interventions based on their genetic risk score results," explained Dr.Hulick. The results will guide more precise treatments for each patient, he added.

NorthShore partnered with Counsyl, a health technology company offering DNA screening for colorectal, breast and prostate cancer risk, which is processing the test results. Patients will be able to check their results on NorthShoreConnect, a secure patient portal. Meeting with a primary care physician or a genetic counselor to discuss results is optional.

"The genetic risk score test is one more example of how we are advancing our approach to personalized medicine," said Dr. Hulick. "To have the opportunity to be one of the first health systems in the country offering genetic tests for tailored risk assessment, screening processes and effective interventions at the primary care physician level is very exciting and promising. It speaks to our vision for an integrated, personalized care approach."