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Phase Ib Biomarker Trial of Naproxen in patients at risk for DNA Mismatch Repair Deficient Colorectal Cancer

The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.


Study Schema

Following informed consent, participants were evaluated at baseline/pre-study based on their registration information, baseline medical history, baseline symptom assessment, baseline laboratory evaluation, and a serum pregnancy test in women of child bearing potential. After eligibility is confirmed, eligible participants will be randomized in either of the following arms; Naproxen 220 mg, Naproxen 440 mg, or placebo for 6 months. The following tests and procedures were performed at Visit 1 and Visit 6; a standard of care lower GI endoscopy with biopsies, urine collection for PGE-M, and blood collection for sequencing studies. The study coordinator will call participants at Visits 2-5 to review any adverse events, assess the use of concomitant medications, and reinforce drug compliance. The post intervention end of study follow up consists of a review of any adverse events two weeks after flexible sigmoidoscopy. If no adverse events were reported, it will be the last visit of the study.