Clinical trial · Interventional
The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Adenomatous Polyp | Colorectal Adenomatous Polyp | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetylsalicylic acid delayed release tablets, 81mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ASA 81mg
- description
- Acetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days.
- interventionNames
- Drug: acetylsalicylic acid delayed release tablets, 81mg
Primary outcomes (4)
- measure
- Uptake of ASA
- timeFrame
- 7 days
- description
- Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).
- measure
- Adherence to ASA over 90 days
- timeFrame
- 90 days
- description
- Number of days taking ASA over a 90 day period. The time (number of days) on ASA for participants that discontinued use will be quantified.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 59 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available