Trial Details

Brief Summary

The overall goal of this study is to develop a platform for both large-scale chemoprevention trials and real-world chemoprevention studies for colorectal cancer (CRC) prevention. The specific objectives of this proof of concept study are to: - Evaluate the feasibility of a real-world chemoprevention agent (CPA) intervention (3-months of daily low-dose acetylsalicylic (ASA)) in participants at increased risk for CRC (one or more high-risk adenomas removed during colonoscopy) based on participant uptake, adherence (days taking CPA), and adverse events; - Evaluate factors related to uptake and adherence of ASA using validated surveys and interviews.

Official Title

The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study

Selection Criteria

Eligibility Inclusion Criteria

Inclusion Criteria:

- Men or women aged 50-59 at time of signing the informed consent
- Documented history of high-risk adenomatous polyps diagnosed within the previous 12 months:

- At least one villous or tubulovillous polyp of any size
- At least one polyp with high-grade dysplasia of any size
- At least one adenomatous polyp ≥1 cm in size
- Three or more tubular adenomas <1 cm in size
- Not currently using ASA for another condition

Eligibility Exclusion Criteria

- Age < 50 or >= 60
- Known allergy or hypersensitivity to ASA, salicylates or non-steroidal anti- inflammatory drugs.
- Daily alcohol use > 3 units
- Regular use of aspirin or non-steroidal anti-inflammatory drugs (> 2 dose/week)
- Current use of corticosteroid (any dose) orally
- Current use of methotrexate, valproic acid or digoxin
- Currently taking any anti-cancer drug
- Current use of anti-platelet agents or anticoagulants
- Anticipated surgical procedure in the next 3 months
- Current or past history of gastrointestinal ulcers
- History of gastrointestinal bleeding (except hemorrhoidal or minor outlet type bleeding)
- Known cirrhosis or hepatic impairment (for example, total bilirubin >1.25 Upper Limit of Normal, International - Normalized Ratio >1.25)
- Known bleeding disorder (hemorrhagic diathesis)
- History of asthma or nasal polyps
- History of colorectal cancer
- Platelet count < 120 or > 450 (within previous 3 months)
- Renal insufficiency (eGFR < 90 within previous 3 months)
- History of congestive heart failure or left ventricular ejection fraction < 50 percent