Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

Undergo collection of blood, urine, stool, and rectal swab samples

Biospecimen Collection

Placebo Administration

Questionnaire Administration

Rectal Biopsy

Qi Dai

This 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.

PRIMARY OBJECTIVE:

I. To test for the equivalency of the two aspirin schedules.

SECONDARY OBJECTIVES:

I. To evaluate the effects of aspirin treatments on:

Ia. The ratio of cell proliferation (Ki-67)/apoptosis (TUNEL) in rectal biopsies; Ib. The ratio of cell proliferation (Ki-67)/necroptosis (pMLKL) in rectal biopsies; Ic. Fecal occult blood test (measures of adverse events) as measured by stool samples.

EXPLORATORY OBJECTIVES:

I. To evaluate the effects of aspirin treatments on:

Ia. Cyclooxygenase-2 (COX-2) in rectal biopsies; Ib. Bcl-2-like protein 4 (BAX) in rectal biopsies; Ic. Transient receptor potential cation channel subfamily M member (7TRPM7) in rectal biopsies; Id. Joint index of COX-2 with TRPM7 expression in rectal biopsies; Ie. Joint index of TRPM7 with BAX in rectal biopsies; If. Methylation assays using the MethylationEPIC BeadChip to identify methylation biomarkers in genes (i.e. CDKN2A \[cell cycle regulation\], MGMT \[deoxyribonucleic acid (DNA) repair\], DAPK1 \[apoptosis\], CDH1 \[cell invasion\], WNT16 \[Wnt pathway\] and RASSF1 \[RAS signaling\]) involved in colorectal carcinogenesis, and other epigenome-wide methylation biomarkers as measured in rectal biopsies; Ig. Metagenomics analysis to measure abundance of Escherichia coli (E. coli) and Fusobacterium and other microbiota in rectal swabs.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive aspirin orally (PO) daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

ARM II: Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

ARM III: Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

After completion of study, patients are followed up at 1 month.

Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma

Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention

Will be summarized using descriptive statistics including means and standard deviations or medians and interquartile range, as well as graphical methods such as "spaghetti plots" that depict change patterns over time. Distributions of each marker will be examined, and values may be transformed as needed to stabilize the variance or satisfy the normality assumption. Correlation between biomarkers, and between pre- and post-treatment values will beexamined using scatterplots with overlayed smoother plots for ease of visual interpretation.

Will be summarized using descriptive statistics including means and standard deviations or medians and interquartile range, as well as graphical methods such as "spaghetti plots" that depict change patterns over time. Distributions of each marker will be examined, and values may be transformed as needed to stabilize the variance or satisfy the normality assumption. Correlation between biomarkers, and between pre- and post-treatment values will be examined using scatterplots with overlayed smoother plots for ease of visual interpretation.

Will be summarized using descriptive statistics including means and standard deviations or medians and interquartile range, as well as graphical methods such as "spaghetti plots" that depict change patterns over time. Distributions of each marker will be examined, and values may be transformed as needed to stabilize the variance or satisfy the normality assumption. Correlation between biomarkers, and between pre-and post-treatment values will beexamined using scatterplots with overlayed smoother plots for ease of visual interpretation.

Will be summarized using descriptive statistics including means and standard deviations or medians and interquartile range, as well as graphical methods such as "spaghetti plots" that depict change patterns over time. Distributions of each marker will be examined, and values may be transformed as needed to stabilize the variance or satisfy the normality assumption. Correlation between biomarkers, and between pre-and post-treatment values will be examined using scatterplots with overlayed smoother plots for ease of visual interpretation.

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 (Chi-square, Fisher) will be provided.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma	NCT02965703	Colorectal Aden...	Aspirin Biospecimen Col... Placebo Adminis... Questionnaire A... Rectal Biopsy	18 Years -	National Cancer Institute (NCI)
Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma	NCT02965703	Colorectal Aden...	Aspirin Biospecimen Col... Placebo Adminis... Questionnaire A... Rectal Biopsy	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for rectal biopsy