ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk -EXTension

NCT05056896 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 5 other identifiers: 21-376R01CA243454R01CA257523R35CA253185-01K01DK120742-01A1
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying a drug intervention as a possible chemoprevention strategy for colorectal cancer. The name of the study intervention involved in this study is:

• Low Dose Aspirin

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Change of ISC marker gene expression

  Assess the difference in the change of ISC marker using scRNA-seq data analysis

  2 months

Secondary Outcomes (5)

• Change in Urinary PGE-M

  2 months

• Change in urinary Plasma GDF-15

  2 months

• ChIP-seq Analysis of Colonic Epithelium

  2 months

• Gene Expression Analysis of Colonic Epithelium

  2 months

• Change in Microbiome

  2 months

Study Arms (2)

Low Dose Aspirin

EXPERIMENTAL

Participants will be randomly assigned to aspirin group and receive a daily low dose aspirin (81 mg) for the duration of the study up to 12 weeks.

Drug: Aspirin

Placebo

EXPERIMENTAL

Participants will be randomly assigned to placebo group and receive a daily placebo capsule for the duration of the study up to 12 weeks.

Other: Placebo

Interventions

Aspirin DRUG

Capsule taken orally

Also known as: acetylsalicylic acid (ASA), Salicylic Acid Acetate

Low Dose Aspirin

Placebo OTHER

Capsule taken orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have undergone screening or surveillance colonoscopy with removal of at least one adenoma within the last 9 months.
• Age greater than or equal to 18 years and less than 55 years or greater than or equal to 65 years at the time of enrollment 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Andrew T Chan, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 27, 2021
• Study Start: June 3, 2022
• Primary Completion: November 27, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)