Status:
UNKNOWN
The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Canadian Cancer Society (CCS)
Conditions:
Colorectal Cancer
Colorectal Adenoma
Eligibility:
All Genders
50-59 years
Phase:
PHASE2
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 objectiv...
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 Screeni...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05402124
Start Date
July 1 2022
End Date
July 1 2023
Last Update
June 2 2022
Active Locations (1)
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1
Forzani & Macphail Colon Cancer Screening Centre, University of Calgary
Calgary, Alberta, Canada, T2N 4N1