Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia
I. Determine whether acetylsalicylic acid (aspirin) will alter spectral markers (i.e.,
spectral slope and fractal dimension) in distal colonic mucosa of patients who are at
increased risk for the development or recurrence of colorectal cancer.
I. Assess the effect of this drug on colonic epithelial apoptosis and cell proliferation in
II. Assess the effect of this drug on rectal prostaglandin levels in these patients.
III. Assess the effect of this drug on platelet cyclooxygenase activity in these patients.
IV. Correlate changes in spectral markers with UGT1A6 genotype in patients treated with this
OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients
are stratified by clinical site and adenoma/carcinoma maximal size. Patients with abnormal
spectral biomarkers are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral acetylsalicylic acid (aspirin) once daily.
ARM II: Patients receive oral placebo once daily.
In both arms, treatment continues for 3 months in the absence of unacceptable toxicity.
Patients undergo flexible sigmoidoscopy and biopsies as well as blood collection at baseline
(during prestudy colonoscopy) and at completion of study treatment for comparison of
spectral signatures with biomarkers of both aspirin activity (including plasma
cyclooxygenase activity and rectal prostaglandin levels) as well as with biomarkers
associated with antineoplastic alteration (including apoptosis and cell proliferation).
UGT1A6 genotyping analysis is also performed.
After completion of study treatment, patients are followed at 3 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Change in spectral slope
The difference in the observed change from baseline in each arm, aspirin and placebo, will be compared.
From baseline to 3 months after completion of study treatment
United States: Institutional Review Board
|Northwestern University||Chicago, Illinois 60611|