A phase Ib biomarker trial of naproxen in patients at risk for DNA mismatch repair deficient colorectal cancer
IRB number: HUM00079757
Enrollment status: Actively enrolling
Lynch syndrome is an inherited disorder that increases the risk of certain types of cancer, particularly cancers of the colon (large intestine) and rectum, which are collectively referred to as colorectal cancer.
This is a biomarker study being conducted to determine if taking naproxen can reduce the risk of colorectal cancer in people with Lynch syndrome. Naproxen is a nonsteroidal antiinflammatory drug (NSAID) that has been marketed under the brand name Aleve®.
- Subjects (male and female), age 18 years and older
Diagnosis of Lynch syndrome
About 60 eligible subjects with Lynch syndrome from multiple centers will be randomized to receive either 220 mg naproxen, 440 mg naproxen, or placebo for up to 6 months.
Over the 6-month study period, be willing to:
- take a study drug once a day.
- come to the University of Michigan for a total of 3 visits.
- undergo a lower GI endoscopy (flexible sigmoidoscopy or colonoscopy) at the beginning and end of the 6-month study period.
Primary investigator: Elena Stoffel, MD, MPH
Co-investigator: D. Kim Turgeon, MD
Study coordinator: Erika Koeppe, e-mail: firstname.lastname@example.org phone: (734) 998-1274