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Do you have chronic ulcerative colitis?

Patients with ulcerative colitis are at higher than average risk of developing cancer of the large intestine (bowel) or colorectal cancer. Doctors at Northwestern Medicine are doing this study to find out if taking the drug atorvastatin might decrease that risk. We are studying atorvastatin because research suggests that it may interfere with cancer development. Atorvastatin is a cholesterol-lowering drug used to treat cardiovascular disease.

 

Better ways to control ulcerative colitis and more knowledge about how to prevent colon cancer are needed. The usual approach for ulcerative colitis patients is to be followed closely by their doctor to watch for the development of cancer, usually with yearly colonoscopy. Drugs proven to help control inflammation (swelling, tenderness, irritation, and abnormal changes) in the colon and a special diet are usually given to ulcerative colitis patients with active inflammation.

I have colon polyps: Welcome

Testing Atorvastatin to lower colon cancer risk in longstanding ulcerative colitis

Principal Investigators:

Guang-Yu Yang, MD, PhD; Stephen Hanauer, MD - Northwestern University

Saurabh Kapur, MD - University of Kansas Medical Center

Joel Pekow, MD - University of Chicago

Victor Carlo, MD - University of Puerto Rico

In this study, you will receive either 20 mg of atorvastatin, or placebo pills, by mouth once a day for up to one year, in addition to your standard of care. This will allow researchers to see if participants taking atorvastatin show changes in their colon, which may indicate a lower risk of developing cancer.

 

After one year of treatment with either atorvastatin or placebo, your study doctor will continue to follow your condition and watch you for side effects for up to 21 days. You should continue your routine yearly surveillance colonoscopy examination.

 

We will enroll about 70 participants. We are looking for volunteers who:

  • Are between 18 and 70 years old

  • Have chronic ulcerative colitis (diagnosed at least 8 years ago)

 

If you think you may be eligible, you can contact the study coordinator.

Northwestern University - Diego Jimenez Lara: (312) 926-4637, diego.jimenez@northwestern.edu

University of Kansas Medical Center - Na Yu: (913) 588-6158 / (913) 954-9419, nyu3@kumc.edu

University of Chicago - Kristin Yates: (773) 834- 8709, kyates@bsd.uchicago.edu

University of Puerto Rico - Heida Rios Soto: (787) 552-3338, hrios@cccupr.org

More Information: https://clinicaltrials.gov/study/NCT04767984

NWU2015-06-01

Additional Resources

Study Brochure 

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Study Video 

Spanish Study Video 

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