NCT05402124

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 50 Years – 59 Years
• Healthy volunteers: Accepted

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: 1. 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; 2. Evaluate factors related to uptake and adherence of ASA using validated surveys and interviews.

Detailed description

Study Design and Duration: This is a single arm (non-randomized), open-label prospective cohort pilot study. Screening Phase: up to 2 weeks Treatment Phase: 90 days Follow-up Phase: 90 days Screening Phase: up to 14 days. Participants will consent to being enrolled in the study and to the use of ASA for a 90 day period. Regardless of agreement to use ASA for the entire study period, all participants will complete 6 baseline questionnaires. Active Treatment Phase: up to 90 days. Participants that agree to the use of ASAs will be instructed to take daily ASAs for 90 days. Participants will be contacted by telephone at 1, 2, and 3 months to determine adverse events, adherence, and discontinuation. At 3 months participants will fill out a chemoprevention questionnaire and the Adherence Barriers Questionnaire (ABQ). Follow-up Phase: 90 days. During the follow-up phase, participants will not be provided with ASA through the study nor will a specific recommendation be made to continue ASA. All participants will be contacted via telephone at the end of this period to determine the prevalence of continued use of ASA on their own. Total study commitment will be up to 194 days. After consent, participants complete a 90 day active treatment phase followed by a 90 day follow-up phase. The trial is expected to be completed within one year.

Conditions

• Colorectal Cancer
• Colorectal Adenoma
• Colorectal Adenomatous Polyp

Interventions

Type	Name	Description
DRUG	acetylsalicylic acid delayed release tablets, 81mg	acetylsalicylic acid delayed release tablets, 81mg taken once per day for 90 days

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-03-01
• Completion: 2023-07-01
• First posted: 2022-06-02
• Last updated: 2022-06-02

Locations

1 site across 1 country: Canada