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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Calgary
• Collaborators: Canadian Cancer Society (CCS); Canadian Institutes of Health Research (CIHR)
• Treatments: Aspirin

Criteria

Inclusion Criteria:

1. Men or women aged 50-59 at time of signing the informed consent

2. Documented history of high-risk adenomatous polyps diagnosed within the previous 12 months:

1. At least one villous or tubulovillous polyp of any size

2. At least one polyp with high-grade dysplasia of any size

3. At least one adenomatous polyp ≥1 cm in size

4. Three or more tubular adenomas <1 cm in size

3. Not currently using ASA for another condition

Exclusion Criteria:

1. Age < 50 or >= 60

2. Known allergy or hypersensitivity to ASA, salicylates or non-steroidal anti- inflammatory drugs.

3. Daily alcohol use > 3 units

4. Regular use of aspirin or non-steroidal anti-inflammatory drugs (> 2 dose/week)

5. Current use of corticosteroid (any dose) orally

6. Current use of methotrexate, valproic acid or digoxin

7. Currently taking any anti-cancer drug

8. Current use of anti-platelet agents or anticoagulants

9. Anticipated surgical procedure in the next 3 months

10. Current or past history of gastrointestinal ulcers

11. History of gastrointestinal bleeding (except hemorrhoidal or minor outlet type bleeding)

12. Known cirrhosis or hepatic impairment (for example, total bilirubin >1.25 Upper Limit of Normal, International Normalized Ratio >1.25)

13. Known bleeding disorder (hemorrhagic diathesis)

14. History of asthma or nasal polyps

15. History of colorectal cancer

16. Platelet count < 120 or > 450 (within previous 3 months)

17. Renal insufficiency (eGFR < 90 within previous 3 months)

18. History of congestive heart failure or left ventricular ejection fraction < 50 percent