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ASPirin Intervention for the REDuction of Colorectal Cancer Risk (ASPIRED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02394769
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Results First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrew T. Chan, MD, MPH, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE March 16, 2015
First Posted Date  ICMJE March 20, 2015
Results First Submitted Date  ICMJE January 29, 2021
Results First Posted Date  ICMJE March 23, 2021
Last Update Posted Date March 23, 2021
Actual Study Start Date  ICMJE July 6, 2015
Actual Primary Completion Date April 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2021)
Change in Urinary Prostaglandin Metabolites (PGE-M) [ Time Frame: 8-12 weeks ]
Measured using liquid chromatography/mass spectrometry
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
Urinary prostaglandin metabolites (PGE-M). [ Time Frame: 8-12 weeks ]
Measured using liquid chromatography/mass spectrometry
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2021)
  • Plasma Macrophage Inhibitory Cytokine-1 (MIC-1), an Inflammatory Biomarker [ Time Frame: 8-12 weeks ]
    Measured using an ELISA for MIC-1
  • Chromatin Binding [ Time Frame: 8-12 weeks ]
    Measured using ChIP-Seq of DNA extracted from colonic epithelium
  • Expression of Wnt-associated Signaling Genes (CTNNB1, AXIN2 and MYC) [ Time Frame: 8-12 weeks ]
    Measured using RNA-seq of colonic epithelium
  • Spectral Biomarkers of Colorectal Cancer [ Time Frame: 8-12 weeks ]
    Measured using Partial Wave Spectroscopy on rectal cytology brushing samples
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
  • Plasma macrophage inhibitory cytokine-1 (MIC-1), an inflammatory biomarker [ Time Frame: 8-12 weeks ]
    Measured using an ELISA for MIC-1
  • Chromatin binding [ Time Frame: 8-12 weeks ]
    Measured using ChIP-Seq of DNA extracted from colonic epithelium
  • Expression of Wnt-associated signaling genes (CTNNB1, AXIN2 and MYC) [ Time Frame: 8-12 weeks ]
    Measured using RNA-seq of colonic epithelium
  • Spectral Biomarkers of Colorectal Cancer [ Time Frame: 8-12 weeks ]
    Measured using Partial Wave Spectroscopy on rectal cytology brushing samples
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ASPirin Intervention for the REDuction of Colorectal Cancer Risk
Official Title  ICMJE ASPIRED: ASPirin Intervention for the REDuction of Colorectal Cancer Risk
Brief Summary This research study is investigating the use of aspirin as a potential chemopreventive agent to reduce risk of colorectal cancer
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Aspirin
    Other Names:
    • 2-Acetylsalicylic Acid
    • ASA
  • Drug: Placebo for Aspirin
Study Arms  ICMJE
  • Placebo Comparator: 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, once daily, until the final visit. Duration not to exceed 12 weeks.
    Intervention: Drug: Placebo for Aspirin
  • Active Comparator: 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 (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.
    Intervention: Drug: Aspirin
  • Active Comparator: Standard 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.
    Intervention: Drug: Aspirin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 16, 2015)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2029
Actual Primary Completion Date April 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Underwent screening or surveillance colonoscopy at MGH within the last 9 months with removal of at least one adenoma.
  • Age 18-80 years.
  • This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults. Patients over age 80 will not be enrolled since the benefits and risks of a daily aspirin regimen over the age of 80 have not yet been well-characterized.
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  • Not currently taking aspirin (any dose) within the last 6 months.
  • The effects of aspirin on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Use of any non-aspirin non-steroidal anti-inflammatory drug (NSAID) at any dose at least three times a week during the two months prior to randomization.
  • Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis
  • Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of non- melanoma skin) in which there has been any active treatment within the last three years
  • Participants who are receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to aspirin.
  • Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).
  • Any adenoma that was not completely removed during previous colonoscopy.
  • History of aspirin intolerance, bleeding diathesis, peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy.
  • Inability or unwillingness to abstain from non-protocol use of aspirin or NSAIDs or to provide blood, urine, or stool samples or colon biopsies during the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or breastfeeding.
  • Pregnant women are excluded from this study because aspirin is an FDA Category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with aspirin, breastfeeding should be discontinued if the mother is treated with aspirin.
  • Participant must be able to swallow pills.
  • Participant is taking any anticoagulant agent (e.g. warfarin) or antiplatelet agent (e.g. clopidogrel).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02394769
Other Study ID Numbers  ICMJE 14-496
R01CA137178 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew T. Chan, MD, MPH, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Andrew T Chan, MD, MPH Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP