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Regenstrief and IU researchers develop and test new tool

Regenstrief Institute and Indiana University School of Medicine research scientists have developed and tested one of the first U.S.-based models to predict personal risk for advanced precancerous polyps and colon cancer in average risk individuals.

Colorectal cancer is the third most common cancer and second most lethal cancer in the U.S.

Especially during the COVID-19 pandemic, when many people are hesitant to visit medical facilities and healthcare resources are stretched, the new risk estimation model could help physicians determine whether an average risk patient’s specific risk indicates an at-home stool test would be a good screening option or points to a colonoscopy as the most appropriate option.

“Our model helps to refine where on the average risk continuum an individual falls,” said study leader Thomas Imperiale, M.D., of Regenstrief Institute and IU School of Medicine. “This information could be used to guide doctor-patient discussions about screening options, with the potential to increase patient acceptance of screening by giving them a choice correlated to their individual risk – true precision medicine. Studies have shown that giving individuals a choice increases screening uptake as many people look for alternatives to colonoscopy.”

Personalized risk-based tailoring of colorectal screening is commonly recommended but not generally used, except for decisions about when to commence screening based on race and family history.

Eight out of 10 individuals who fall within the range for whom colorectal cancer screening is recommended by national guidelines are considered to be at average risk of the disease. The new predictive model for average risk individuals considers age, sex, lifestyle, diet, smoking history and eight other factors.

The study deriving and validating the tool evaluated 4,500 individuals ages 50 to 80 who had not had a previous colonoscopy and identified sizeable lower risk and higher risk groups among average risk individuals. About a quarter of average risk individuals in the study were found to be at 2 percent risk, which is considered low risk. Approximately 60 percent were found to be medium risk, reflective of truer “average risk.” About 10 percent were deemed high risk for which a screening colonoscopy is appropriate.

“The importance of colorectal cancer screening cannot be overstated,” said Dr. Imperiale. “A home annual FIT [fecal immunochemical test] testing, which looks for blood in the stool and is inexpensive, or stool DNA and blood testing every three years, are efficient ways to screen those at the low-risk end of the average risk population. “Particularly during the COVID-19 pandemic, as we see people less willing to consider screening colonoscopies, having an accurate risk assessment tool to determine for whom other options are perfectly good and letting them know which options are suitable is essential. It also has the added benefits of enabling us to prioritize those who are in greatest need of colonoscopy while conserving potentially scare resources — from masks and other PPE (personal protective equipment) to the ancillary costs of anesthesia.”

Derivation and validation of a predictive model for advanced colorectal neoplasia in asymptomatic adults” is published in Gut, an official journal of the British Society of Gastroenterology, published by BMJ. Authors of the study, in addition to Dr. Imperiale are Patrick Monahan, PhD and Timothy Stump, M.A. of IU School of Medicine’s Department of Biostatistics and David Ransohoff, M.D. of the University of North Carolina at Chapel Hill.

This work was supported by the National Cancer Institute (R01-CA104459); Walther Cancer Institute; Indiana University Melvin and Bren Simon Comprehensive Cancer Center; and Indiana Clinical and Translational Sciences Institute (grant UL1TR001108) from the National Center for Research Resources, National Institutes of Health.

About Regenstrief Institute

Founded in 1969 in Indianapolis, the Regenstrief Institute is a local, national and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its research scientists are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform practice and improve the lives of patients around the globe.

Sam Regenstrief, a nationally successful entrepreneur from Connersville, Indiana, founded the institute with the goal of making healthcare more efficient and accessible for everyone. His vision continues to guide the institute’s research mission.

About IU School of Medicine

IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.

Thomas F. Imperiale, M.D.

In addition to his role as a research scientist at Regenstrief Institute, Thomas F. Imperiale, M.D., is a core investigator for the U.S. Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, Richard L. Roudebush VA Medical Center. He is the Lawrence Lumeng Professor of Gastroenterology and Hepatology at Indiana University School of Medicine and a member of the Indiana University Melvin and Bren Simon Comprehensive Cancer Center. He is also a practicing gastroenterologist whose clinical responsibilities include performing colonoscopies.

MEDIA CONTACTS:
John Erickson
Regenstrief Institute
prteam@regenstrief.org
(317) 643-2313
Cindy Fox Aisen
Regenstrief Institute
caisen@regenstrief.org
(317) 843-2275

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