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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED): a study protocol for a randomized controlled trial

Authors: David A. Drew, Samantha M. Chin, Katherine K. Gilpin, Melanie Parziale, Emily Pond, Madeline M. Schuck, Kathleen Stewart, Meaghan Flagg, Crystal A. Rawlings, Vadim Backman, Peter J. Carolan, Daniel C. Chung, Francis P. Colizzo III, Matthew Freedman, Manish Gala, John J. Garber, Curtis Huttenhower, Dmitriy Kedrin, Hamed Khalili, Douglas S. Kwon, Sanford D. Markowitz, Ginger L. Milne, Norman S. Nishioka, James M. Richter, Hemant K. Roy, Kyle Staller, Molin Wang, Andrew T. Chan

Published in: Trials | Issue 1/2017

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Abstract

Background

Although aspirin is recommended for the prevention of colorectal cancer, the specific individuals for whom the benefits outweigh the risks are not clearly defined. Moreover, the precise mechanisms by which aspirin reduces the risk of cancer are unclear. We recently launched the ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED) trial to address these uncertainties.

Methods/design

ASPIRED is a prospective, double-blind, multidose, placebo-controlled, biomarker clinical trial of aspirin use in individuals previously diagnosed with colorectal adenoma. Individuals (n = 180) will be randomized in a 1:1:1 ratio to low-dose (81 mg/day) or standard-dose (325 mg/day) aspirin or placebo. At two study visits, participants will provide lifestyle, dietary and biometric data in addition to urine, saliva and blood specimens. Stool, grossly normal colorectal mucosal biopsies and cytology brushings will be collected during a flexible sigmoidoscopy without bowel preparation. The study will examine the effect of aspirin on urinary prostaglandin metabolites (PGE-M; primary endpoint), plasma inflammatory markers (macrophage inhibitory cytokine-1 (MIC-1)), colonic expression of transcription factor binding (transcription factor 7-like 2 (TCF7L2)), colonocyte gene expression, including hydroxyprostaglandin dehydrogenase 15-(NAD) (HPGD) and those that encode Wnt signaling proteins, colonic cellular nanocytology and oral and gut microbial composition and function.

Discussion

Aspirin may prevent colorectal cancer through multiple, interrelated mechanisms. The ASPIRED trial will scrutinize these pathways and investigate putative mechanistically based risk-stratification biomarkers.

Trial registration

This protocol is registered with the U.S. National Institutes of Health trial registry, ClinicalTrials.gov, under the identifier NCT02394769. Registered on 16 March 2015.
Appendix
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Metadata
Title
ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED): a study protocol for a randomized controlled trial
Authors
David A. Drew
Samantha M. Chin
Katherine K. Gilpin
Melanie Parziale
Emily Pond
Madeline M. Schuck
Kathleen Stewart
Meaghan Flagg
Crystal A. Rawlings
Vadim Backman
Peter J. Carolan
Daniel C. Chung
Francis P. Colizzo III
Matthew Freedman
Manish Gala
John J. Garber
Curtis Huttenhower
Dmitriy Kedrin
Hamed Khalili
Douglas S. Kwon
Sanford D. Markowitz
Ginger L. Milne
Norman S. Nishioka
James M. Richter
Hemant K. Roy
Kyle Staller
Molin Wang
Andrew T. Chan
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1744-z

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