This randomized clinical trial studies the use of aspirin in preventing colorectal cancer in patients who have undergone colonoscopy and removal of a tumor that is not cancer (adenoma). Studying samples of blood, saliva, and urine may help doctors learn about the effects of aspirin on the body’s immune response and define the best dose to use.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02394769.
PRIMARY OBJECTIVES:
I. To measure the effect of low-dose and standard-dose aspirin treatment on urinary prostaglandin metabolites (PGE-M).
SECONDARY OBJECTIVES:
I. To measure the dose-dependent effects of aspirin on the following colorectal cancer-associated biomarkers: plasma macrophage inhibitory cytokine-1 (MIC-1), an inflammatory biomarker; TCF7L2/TCF4 binding at the 8q24 colorectal cancer risk locus in colonic epithelium; Wnt signaling genes (i.e. beta-catenin, AXIN-2 and MYC) and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) gene expression as measured by ribonucleic acid (RNA)-sequence (seq) on sorted colonic epithelial cell populations; bacterial populations and products associated with colorectal cancer in saliva and stool; spectral biomarkers of colorectal carcinogenesis from cytology brushings.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A (LOW-DOSE ASPIRIN): Patients receive low-dose aspirin orally (PO) once daily (QD) for 8-12 weeks.
ARM B (STANDARD-DOSE ASPIRIN): Patients receive standard-dose aspirin PO QD for 8-12 weeks.
ARM C (PLACEBO): Patients receive placebo PO QD for 8-12 weeks.
After completion of study treatment, patients are followed up 1-2 times every year.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAndrew T Chan