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

Last updated: May 27, 2022
Sponsor: University of Calgary
Overall Status: Active - Not Recruiting

Phase

2

Condition

Colon Cancer

Colon Polyps

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT05402124
CRC-CHAMP01
  • Ages 50-59
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 12months:
  3. At least one villous or tubulovillous polyp of any size
  4. At least one polyp with high-grade dysplasia of any size
  5. At least one adenomatous polyp ≥1 cm in size
  6. Three or more tubular adenomas <1 cm in size
  7. Not currently using ASA for another condition

Exclusion

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 typebleeding)
  12. Known cirrhosis or hepatic impairment (for example, total bilirubin >1.25 Upper Limitof 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

Study Design

Total Participants: 100
Study Start date:
July 01, 2022
Estimated Completion Date:
July 31, 2023

Study 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.

Connect with a study center

  • Forzani & Macphail Colon Cancer Screening Centre, University of Calgary

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.