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

NCT05402124 | Unknown Phase 2

• 1 other identifier: CRC-CHAMP01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 objectives of this proof of concept study are to:

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

Conditions

Colorectal Cancer; Colorectal Adenoma; Colorectal Adenomatous Polyp

Outcome Measures

Primary Outcomes (4)

• Uptake of ASA

  Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).

  7 days

• Adherence to ASA over 90 days

  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.

  90 days

• Adherence to at least 50 percent of total prescribed dose

  Percentage of participants who take at least 50 percent of total prescribed dose. Descriptive statistics will be utilized to characterize participants that adhered to ASA and participants who did not.

  90 days

• Measurement of Adverse Events

  Measurement of Adverse Events reported through interviews with research study nurse and participant report over 90 days (active treatment phase).

  90 days

Secondary Outcomes (6)

• Factors related to uptake and adherence to ASA

  From enrollment to 90 days

• Factors related to uptake and adherence to ASA using measurement of health related quality of life

  At enrollment

• Factors related to uptake and adherence to ASA using measurement of self efficacy

  At enrollment

• Factors related to uptake and adherence to ASA

  At enrollment

• Factors related to uptake, in-study adherence and post-study maintenance using measurement of adherence barriers

  At enrollment through end of treatment at 90 days

Study Arms (1)

ASA 81mg

OTHER

Acetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days.

Drug: acetylsalicylic acid delayed release tablets, 81mg

Interventions

acetylsalicylic acid delayed release tablets, 81mg DRUG

acetylsalicylic acid delayed release tablets, 81mg taken once per day for 90 days

Also known as: ASPIRIN 81mg, Drug Identification Number 02237726

ASA 81mg

Eligibility Criteria

• Age: 50 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

Forzani & Macphail Colon Cancer Screening Centre, University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Robert Hilsden

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Hilsden

CONTACT

403 592 5089; rhilsden@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm, open-label, prospective cohort pilot study.

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 2, 2022
• Study Start: July 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)