Clinical Trial: Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention
Brief Summary: This randomized phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Summary:
PRIMARY OBJECTIVES:
I. To test for the equivalency of the two aspirin schedules.
SECONDARY OBJECTIVES:
I. To evaluate the effects of aspirin treatments on the ratio of cell proliferation (Ki-67)/apoptosis (TUNEL) in rectal biopsies.
II. To evaluate the effects of aspirin treatments on the ratio of cell proliferation (Ki-67)/necroptosis (MLKL) in rectal biopsies.
III. To evaluate the effects of aspirin treatments on fecal occult blood test (measures of adverse events) as measured by stool samples.
IV. To evaluate the effects of aspirin treatments on methylation biomarkers in genes (i.e. CDKN2A [cell cycle regulation], MGMT [DNA repair], DAPK1 [apoptosis], CDH1 [cell invasion], WNT16 [Wnt pathway] and RASSF1 [RAS signaling]) involved in colorectal carcinogenesis, as measured in rectal biopsies.
V. To evaluate the effects of aspirin treatments on colorectal mucosal nanoscale cellular structural changes measured by PWS (partial wave spectroscopy) obtained through rectal brushings.
VI. To evaluate the effects of aspirin treatments on abundance of E. coli and Fusobacterium in rectal swabs.
VII. To evaluate if the effects of aspirin arms may be modified by dietary intake of calcium as measured by the Food Frequency Questionnaire (FFQ).
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive aspirin orally (PO) daily for 12 weeks.
Same as current
Current Secondary Outcome:
- Abundance of E. coli and fusobacterium assessed by rectal swabs [ Time Frame: Up to 9 months ]All of these variables will be described using appropriate statistics such as means (for continuous) and proportions (for discrete outcomes). Typically, basic scientists like to present the data to each other as bar graphs with standard deviation/standard error bars. Such and other, more appropriate graphic presentations, as confidence intervals for the true mean or true proportion will be provided, as well as scatter plots presenting two variables relationship in the Cartesian axes context. Tests of difference for continuous data (t-test, Wilcoxon test) and of association for discrete data (C
- Change in colorectal mucosal nanoscale cellular structural assessed by rectal brushing by partial wave spectroscopy [ Time Frame: Baseline to 9 months ]All of these variables will be described using appropriate statistics such as means (for continuous) and proportions (for discrete outcomes). Typically, basic scientists like to present the data to each other as bar graphs with standard deviation/standard error bars. Such and other, more appropriate graphic presentations, as confidence intervals for the true mean or true proportion will be provided, as well as scatter plots presenting two variables relationship in the Cartesian axes context. Tests of difference for continuous data (t-test, Wilcoxon test) and of association for discrete data (C
- Dietary intake of calcium measured by the Food Frequency Questionnaire [ Time Frame: Up to 9 months ]All of these variables will be described using appropriate statistics such as means (for continuous) and proportions (for discrete outcomes). Typically, basic scientists like to present the data to each other as bar graphs with standard deviation/standard error bars. Such and other, more appropriate graphic presentations, as confidence intervals for the true mean or true proportion will be provided, as well as scatter plots presenting two variables relationship in the Cartesian axes context. Tests of difference for continuous data (t-test, Wilcoxon test) and of association for discrete data (C
- Fecal occult blood test assessed in stool samples [ Time Frame: Up to 12 weeks ]All of these variables will be described using appropriate statistics such as means (for continuous) and proportions (for discrete outcomes). Typically, basic scientists like to present the data to each other as bar graphs with standard deviation/standard error bars. Such and other, more appropriate graphic presentations, as confidence intervals for the true mean or true proportion will be provided, as well as scatter plots presenting two variables relationship in the Cartesian axes context. Tests of difference for continuous data (t-test, Wilcoxon test) and of association for discrete data (C
- Methylation in CDKN2A (cell cycle regulation), MGMT (DNA repair), DAPK1(apoptosis), CDH1(cell invasion), WNT16 (Wnt pathway), and RASSF1 (RAS signaling) assessed by pyrosequencing method [ Time Frame: Up to 12 weeks ]All of these variables will be described using appropriate statistics such as means (for continuous) and proportions (for discrete outcomes). Typically, basic scientists like to present the data to each other as bar graphs with standard deviation/standard error bars. Such and other, more appropriate graphic presentations, as confidence intervals for the true mean or true proportion will be provided, as well as scatter plots presenting two variables relationship in the Cartesian axes context. Tests of difference for continuous data (t-test, Wilcoxon test) and of association for discrete data (C
- Ratio of cell proliferation (Ki-67)/apoptosis (TUNEL) assessed in rectal biopsies [ Time Frame: Up to 12 weeks ]All of these variables will be described using appropriate statistics such as means (for continuous) and proportions (for discrete outcomes). Typically, basic scientists like to present the data to each other as bar graphs with standard deviation/standard error bars. Such and other, more appropriate graphic presentations, as confidence intervals for the true mean or true proportion will be provided, as well as scatter plots presenting two variables relationship in the Cartesian axes context. Tests of difference for continuous data (t-test, Wilcoxon test) and of association for discrete data (C
- Ratio of cell proliferation (Ki-67)/necroptosis (MLKL) assessed in rectal biopsies [ Time Frame: Up to 12 weeks ]All of these variables will be described using appropriate statistics such as means (for continuous) and proportions (for discrete outcomes). Typically, basic scientists like to present the data to each other as bar graphs with standard deviation/standard error bars. Such and other, more appropriate graphic presentations, as confidence intervals for the true mean or true proportion will be provided, as well as scatter plots presenting two variables relationship in the Cartesian axes context. Tests of difference for continuous data (t-test, Wilcoxon test) and of association for discrete data (C
Original Secondary Outcome: Same as current
Information By: National Cancer Institute (NCI)
Dates:
Date Received: November 16, 2016
Date Started: May 25, 2017
Date Completion: February 1, 2020
Last Updated: May 1, 2017
Last Verified: May 2017
