Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer
Recruitment status was: Active, not recruiting
Drug: acetylsalicylic acid
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia|
- Change in spectral slope [ Time Frame: From baseline to 3 months after completion of study treatment ]The difference in the observed change from baseline in each arm, aspirin and placebo, will be compared.
- Change in fractal dimension [ Time Frame: From baseline to 3 months after completion of study treatment ]The difference in the observed change from baseline in each arm, aspirin and placebo, will be compared.
- Colonic epithelial apoptosis as measured by immunohistochemical detection of cleaved caspase 3 [ Time Frame: Up to 3 months after completion of study treatment ]
- Colonic cell proliferation as measured by immunohistochemical detection of Ki67 [ Time Frame: Up to 3 months after completion of study treatment ]
- Rectal prostaglandin levels as measured by ELISA [ Time Frame: Up to 3 months after completion of study treatment ]
- Platelet cyclooxygenase (COX) activity as measured by a peroxidase-based COX enzyme activity assay [ Time Frame: Up to 3 months after completion of study treatment ]
|Study Start Date:||March 2007|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral acetylsalicylic acid (aspirin) once daily.
Drug: acetylsalicylic acid
Other Names:Other: laboratory biomarker analysis
Placebo Comparator: Arm II
Patients receive oral placebo once daily.
Other Name: PLCBOther: laboratory biomarker analysis
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 these patients.
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 drug.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468910
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Hemant Roy||Northwestern University|