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Trials. 2017 Feb 1;18(1):50. doi: 10.1186/s13063-016-1744-z.

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

Author information

1
Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
2
Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
3
The Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.
4
McCormick School of Engineering, Northwestern University, Evanston, IL, USA.
5
Broad Institute, Cambridge, MA, USA.
6
Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
7
Case Western Reserve University School of Medicine and University Hospitals of Cleveland, Cleveland, OH, USA.
8
Eicosanoid Core Laboratory, Division of Clinical Pharmacology, Vanderbilt University, Nashville, TN, USA.
9
Section of Gastroenterology, Boston Medical Center, Boston, MA, USA.
10
Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
11
Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
12
Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. achan@mgh.harvard.edu.
13
Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. achan@mgh.harvard.edu.
14
Broad Institute, Cambridge, MA, USA. achan@mgh.harvard.edu.
15
Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. achan@mgh.harvard.edu.
16
Division of Gastroenterology and Clinical and Translational Epidemiology Unit, Massachusetts General Hospital, GRJ-825C, Boston, MA, 02114, USA. achan@mgh.harvard.edu.

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.

KEYWORDS:

Aspirin; Biomarker; Chemoprevention; Colorectal cancer

PMID:
28143522
PMCID:
PMC5286828
DOI:
10.1186/s13063-016-1744-z
[Indexed for MEDLINE]
Free PMC Article

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