Colorectal CancerPhase 2NCT05402124
The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
A Phase 2 study testing acetylsalicylic acid delayed release tablets, 81mg in people with Colorectal Cancer and Colorectal Adenoma, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma, Colorectal Adenomatous Polyp
- What is being tested?
- acetylsalicylic acid delayed release tablets, 81mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2022to Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Forzani & Macphail Colon Cancer Screening Centre, University of Calgary
Calgary, Alberta, T2N 4N1
Robert Hilsden, 1 403 592 5089, rhilsden@ucalgary.ca
Susanna Town, 1 403 592 5052, susanna.town@ucalgary.ca
About this study
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:
- 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;
- Evaluate factors related to uptake and adherence of ASA using validated surveys and interviews.
Read the 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
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.
- Being tested
- acetylsalicylic acid delayed release tablets, 81mg
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acid delayed release tablets, 81mgDrug
Also called ASPIRIN 81mg, Drug Identification Number 02237726
acetylsalicylic acid delayed release tablets, 81mg taken once per day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| ASA 81mg | Other | Acetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days. Receives: Drug: acetylsalicylic acid delayed release tablets, 81mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of ASA
Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 90 days
Secondary outcomes (6)
Factors related to uptake and adherence to ASA
Behavioral, sociodemographic and health characteristics, measured using Health \& Lifestyle Questionnaire and presented as percentages.
Measured: From enrollment to 90 days
Factors related to uptake and adherence to ASA using measurement of health related quality of life
Behavioral, sociodemographic and health characteristics, measured using Short-Form 36 Health Survey Questionnaire to measure quality of life and presented as percentages.
Measured: At enrollment
Factors related to uptake and adherence to ASA using measurement of self efficacy
Behavioral, sociodemographic and health characteristics, measured using National Institutes of Health (NIH) Self-efficacy questionnaire and presented as percentages.
Measured: At enrollment
Factors related to uptake and adherence to ASA
Measurement of beliefs, attitudes and values about medicines using Beliefs about Medicines questionnaire and expressed as percentages.
Measured: At enrollment
Factors related to uptake, in-study adherence and post-study maintenance using measurement of adherence barriers
Measurement of Adherence barriers using Adherence Barriers Questionnaire (at baseline and 3m follow-up) and expressed as percentages.
Measured: At enrollment through end of treatment at 90 days
Factors related to uptake, in-study adherence and post-study maintenance using measurement of chemoprevention knowledge
Measurement of knowledge about chemoprevention using Chemoprevention Questionnaires (baseline and 3m follow-up) and expressed as percentages.
Measured: At enrollment through end of treatment at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm, open-label, prospective cohort pilot study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
- Responsible party
- Sponsor
- Investigators
- Robert Hilsden, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402124
- Sponsor's protocol ID
- CRC-CHAMP01
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with researchers other than the Principal and Co-investigators. The results of this study will be published in a scientific peer reviewed journal. Both the chemoprevention intervention results and the feasibility results for scaling a chemoprevention program to all individuals attending a screening center will be presented. The qualified investigator holds the primary responsibility for publication of study results.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
- ClinicalTrials.gov ID
- NCT05402124
- Acronym / sponsor ID
- CRC-CHAMP01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
- Study start
- Jul 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- Evaluate factors related to uptake and adherence of ASA using validated surveys and interviews.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm, open-label, prospective cohort pilot study.
| Arm | Type | Receives |
|---|---|---|
| ASA 81mg | Other | Drug: acetylsalicylic acid delayed release tablets, 81mgAcetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days. |
Who may qualify
- Ages
- 50 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
- Not currently using ASA for another condition
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicylic acid delayed release tablets, 81mgAlso: ASPIRIN 81mg, Drug Identification Number 02237726acetylsalicylic acid delayed release tablets, 81mg taken once per day for 90 days | Drug | ASA 81mg |
Primary outcome
Uptake of ASA
Time frame: 7 days
Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).
Adherence to ASA over 90 days
Time frame: 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.
Adherence to at least 50 percent of total prescribed dose
Time frame: 90 days
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.
Measurement of Adverse Events
Time frame: 90 days
Measurement of Adverse Events reported through interviews with research study nurse and participant report over 90 days (active treatment phase).
6 secondary outcomes
Factors related to uptake and adherence to ASA
Time frame: From enrollment to 90 days
Factors related to uptake and adherence to ASA using measurement of health related quality of life
Time frame: At enrollment
Factors related to uptake and adherence to ASA using measurement of self efficacy
Time frame: At enrollment
Factors related to uptake and adherence to ASA
Time frame: At enrollment
Factors related to uptake, in-study adherence and post-study maintenance using measurement of adherence barriers
Time frame: At enrollment through end of treatment at 90 days
Factors related to uptake, in-study adherence and post-study maintenance using measurement of chemoprevention knowledge
Time frame: At enrollment through end of treatment at 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with researchers other than the Principal and Co-investigators. The results of this study will be published in a scientific peer reviewed journal. Both the chemoprevention intervention results and the feasibility results for scaling a chemoprevention program to all individuals attending a screening center will be presented. The qualified investigator holds the primary responsibility for publication of study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hilsden principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acetylsalicylic acid delayed release tablets, 81mg in people with Colorectal Cancer and Colorectal Adenoma, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Hilsden (403 592 5089, rhilsden@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of ASA (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.