February 8, 2002
Gene-Based Cancer Test Studied
CHICAGO— Northwestern University Medical School is testing an investigational, noninvasive, gene-based screening method for colorectal cancer, the second-leading cause of cancer death in the United States. Around 57,000 Americans die of colon cancer each year. The test, called the PreGen-Plus, uses a technique similar to that described in an article in the Jan. 31 issue of The New England Journal of Medicine. The test analyzes the DNA in a stool sample and checks for changes that develop during the precancerous and cancerous stages of colorectal cancer.
The stool test does not look for inherited conditions or risks, only specific changes in the DNA of colon and rectal cells that are associated with the development of colorectal cancer.
The gene-based screening test may be an alternative to some of the current first-line screening methods used for colorectal cancer, such as fecal occult blood tests (FOBTs), which are designed to detect blood in a stool sample.
Researchers in the study will compare the accuracy of the gene-based screening test for colorectal cancer vs. that with FOBT. The accuracy of both tests will be assessed based on the findings at a follow-up colonoscopy.
Colin Howden, M.D., a gastrointerologist and professor of medicine, is the principal investigator for the study at Northwestern. The study, which is sponsored by Massachusetts-based EXACT Sciences Corporation, will enroll approximately 5,000 individuals at Northwestern and other medical centers in the United Sates.
Colonoscopy is widely viewed as the best currently available method for detecting colorectal cancer because of its accuracy and ability to examine the entire colon while also removing or taking samples from suspect growths. Since colonoscopy is invasive and expensive, an accurate, first-line test is important to determine if a colonoscopy is necessary.
Women and men aged 65 and older who have not had a colonoscopy in the past 10 years are qualified to enroll in this research study. Participants will be asked to provide one stool sample for the investigational EXACT PreGen-Plus test, complete a Hemoccult® test and undergo a colonoscopy.
The study-related stool tests and lab analysis are provided at no cost. The colonoscopy will be billed to the partipant’s health insurance, such as Medicare. (As of July 1, 2001, Medicare beneficiaries are covered for a screening colonoscopy every 10 years.) In addition, study participants will be compensated financially.
For more information on the colorectal cancer screening study, call the Northwestern Center for Clinical Research at (312) 503-6227.