Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

Placebo for Aspirin

Andrew T Chan, MD, MPH

This research study is investigating the use of aspirin as a potential chemopreventive agent to reduce risk of colorectal cancer

This research study, is investigating the use of aspirin as a potential chemopreventive agent to reduce risk of colorectal cancer. Within the gastroenterology practice of Massachusetts General Hospital (MGH), we will conduct a prospective, double-blind, placebo-controlled, randomized clinical trial to measure the effects of daily low-dose (81 mg/day) and standard-dose (325 mg/day) aspirin on urine, plasma, stool, and tissue biomarkers associated with colorectal cancer.

Aspirin is part of the non-steroidal anti-inflammatory drug (NSAID) family, which are drugs routinely used for their pain-killing (analgesic), fever-reducing (antipyretic), or anti-inflammatory properties. Most NSAIDs are available as over-the-counter formulations. Substantial evidence has conclusively demonstrated that aspirin reduces the risk of colorectal neoplasia, yet there remains uncertainty surrounding its mode of action. Aspirin has already been established to reduce the risk of cardiovascular disease. Prospective studies as well as randomized clinical trials demonstrate that aspirin reduces the risk of precancerous polyps and colorectal cancer.

ASPirin Intervention for the REDuction of Colorectal Cancer Risk

ASPIRED: ASPirin Intervention for the REDuction of Colorectal Cancer Risk

Measured using liquid chromatography/mass spectrometry

Measured using ChIP-Seq of DNA extracted from colonic epithelium

Measured using RNA-seq of colonic epithelium

Measured using Partial Wave Spectroscopy on rectal cytology brushing samples

National Cancer Institute (NCI)

Massachusetts General Hospital

Principal Investigator

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.

Placebo for Aspirin

Placebo (For Aspirin)

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

Aspirin

Low Dose Aspirin

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

Aspirin

Standard Dose Aspirin

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Marital status

Body Mass Index

Body Mass Index, categories

Smoking status

Alcohol consumption

Personal cancer history, yes

Family history of colorectal cancer, yes

Type II diabetes, yes

Premenopausal

Perimenopausal

Postmenopausal

Missing

Menopausal status of female participants, only

Menopause status

History of 81 mg aspirin use

History of 325 mg aspirin use

History of non-steroidal anti-inflammatory drug use

Proton pump inhibitor use

H2-blocker use

Antacid use

Statin use

Andrew T. Chan, MD, MPH

Baseline urinary PGE-M

Post-intervention urinary PGE-M

Change in urinary PGE-M

Change in Urinary Prostaglandin Metabolites (PGE-M)

Plasma Macrophage Inhibitory Cytokine-1 (MIC-1), an Inflammatory Biomarker

Chromatin Binding

Expression of Wnt-associated Signaling Genes (CTNNB1, AXIN2 and MYC)

Spectral Biomarkers of Colorectal Cancer

Overall Study

Spots Global Cancer Trial Database for placebo for aspirin