Colorectal CancerPRESENTNCT05357508
Colorectal Cancer Screening Based on Predicted Risk
A study testing Intervention brochure in people with Colorectal Cancer, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
Trial summary
The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC. Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Intervention brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Interventional
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 50 and 69;
- Residents of the Canton of Vaud;
- Have signed an informed consent (paper or electronic).
Who cannot join
- Current CRC symptoms;
- Personal CRC history;
- In colonoscopy surveillance for follow-up of high-risk polyp(s);
- Inflammatory bowel disease;
- Having done a colonoscopy within 9 years or a FIT within 1,5 years;
- Planning to leave Switzerland definitively within the next six months.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Primary Care and Public Health (Unisante)
Lausanne, Canton of Vaud, 1011
About this study
Official title: Protocol Title: Colorectal Cancer Screening Decisions Based on Predicted Risk: the PREcision ScreENing Randomized Controlled Trial (PRESENT)
The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.
The secondary objectives:
Read more
- Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes;
- Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates.
The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of participants' risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to a participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.
This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.
Read the detailed description
Colorectal cancer (CRC) can be effectively prevented by screening. Risk to develop CRC within 15 years is related to increasing age, sex, family history, and lifestyle and, thus, can vary from <1% to >15%.
Fecal immunochemical test (FIT) and colonoscopy are the most widely used screening tests. Colonoscopy is the most accurate test, but is related to risks of bleeding and perforation. Colonoscopy resources are limited, and high uptake of screening colonoscopy for low-risk individuals can cause long wait times for those with CRC symptoms or positive FIT. FIT is less costly can be done at home without preparation and, if done regularly, prevents most CRC mortality, especially in moderate and low-risk individuals. To offer the screening options with a reasonable risk-benefit balance, FIT should be recommended to individuals at low (<3% to develop CRC in 15 years) and moderate (3-6%) risk, and colonoscopy to those at high (>6%) risk.
The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.
The secondary objectives:
- Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes;
- Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates.
The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of the participant's risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.
This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.
- Conditions
- Colorectal Cancer
- Being tested
- Intervention brochure, Control brochure
- Keywords
- Colorectal Cancer Screening, Personalized Risk, Risk Communication, Shared Decision Making, Screening Behavior
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention brochureBehavioural
Provide participants with information about their personalized risk for colorectal cancer and appropriate screening recommendations to facilitate their screening option choice.
Control brochureBehavioural
Provide participants with general information about options for colorectal cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the Intervention group receive a brochure with their personalized risk score for colorectal cancer and screening recommendations (FIT or colonoscopy) corresponding to their risk level. Receives: Behavioral: Intervention brochure |
| Usual care group | Active comparator | Participants in the Usual care group receive the standard brochure designed by the Vaud screening program. This brochure recommends screening to all individuals beginning at age 50 and presents both FIT and colonoscopy as equal options. Receives: Behavioral: Control brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported appropriate screening uptake
Proportion who completed screening test appropriate to risk level. For low risk (<3% 15-yr CRC risk), completing a FIT. For intermediate risk (3-6%15-yr CRC risk), completing a FIT, completing a colonoscopy, or having a colonoscopy appointment. For high risk (>6% 15-yr CRC risk), completing a colonoscopy or having a colonoscopy appointment.
Measured: 6-8 months after the intervention
Secondary outcomes (6)
Self-reported overall screening participation
Proportion who completed any CRC screening test (FIT, colonoscopy, colonoscopy appointment, CT colonography, blood test, etc.
Measured: 6-8 months after the intervention
Participation in the randomized trial
Proportion of those invited with completed paper or electronic consent
Measured: 6 weeks after mailed invitations
Eligibility for the Vaud CRC screening program
Proportion of those who returned the baseline questionnaire who are eligible for the Vaud screening program (i.e. not up-to-date with screening, not in colonoscopy surveillance, no personal CRC history, etc.)
Measured: 6 weeks after mailed invitations
Self-reported anxiety
Mean anxiety score using adapted questions from a standardized questionnaire (STAI Fr)
Measured: 6 weeks after mailed invitations
Linkage to Vaud CRC screening program
Proportion of study participants who consent and whose screening status are obtained from the Vaud CRC screening program
Measured: 3-6 months after measurement of primary outcome
Linkage to Vaud tumor registry
Proportion of study participants who consent and whose cancer status are obtained from the Vaud tumor registry. Long time frame chosen given considerable delay in updating the tumor registry and interest in cancer outcomes several years after measurement of primary outcome.
Measured: 6 months to 10 years after measurement of primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 May 2022
- Primary completion31 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Selby, MD, MAS, Principal investigator, Center for Primary Care and Public Health (Unisanté)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357508
- Sponsor's protocol ID
- PRESENT STUDY
- Acronym
- PRESENT
- Status last verified
- May 2024
- First submitted
- 19 Apr 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon publication of the primary results, the data that support the findings of this study will be available from the corresponding author upon reasonable request.
Publications
Hippisley-Cox J, Coupland C. Development and validation of risk prediction algorithms to estimate future risk of common cancers in men and women: prospective cohort study. BMJ Open. 2015 Mar 17;5(3):e007825. doi: 10.1136/bmjopen-2015-007825.
PubMed 25783428Samusure J, Horisberger D, Diserens C, Ducros C, Auer R, Bodenmann P, Durand MA, Selby K. [Information materials for colorectal cancer screening for citizens with low health literacy]. Rev Med Suisse. 2022 Mar 30;18(775):616-620. doi: 10.53738/REVMED.2022.18.775.616. French.
PubMed 35353458Plys E, Bulliard JL, Chaouch A, Durand MA, van Duuren LA, Brandle K, Auer R, Froehlich F, Lansdorp-Vogelaar I, Corley DA, Selby K. Colorectal Cancer Screening Decision Based on Predicted Risk: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 7;12:e46865. doi: 10.2196/46865.
PubMed 37676720Plys E, Bulliard JL, Chaouch A, Durand MA, van Duuren LA, Braendle K, Auer R, Froehlich F, Lansdorp-Vogelaar I, Corley DA, Selby K. Colorectal Cancer Screening Based on Predicted Risk: A Randomized Controlled Trial. Am J Gastroenterol. 2025 Oct 1;120(10):2432-2439. doi: 10.14309/ajg.0000000000003311. Epub 2025 Jan 7.
PubMed 39774118
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Title: Colorectal Cancer Screening Decisions Based on Predicted Risk: the PREcision ScreENing Randomized Controlled Trial (PRESENT)
- ClinicalTrials.gov ID
- NCT05357508
- Acronym / sponsor ID
- PRESENT / PRESENT STUDY
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer Screening, Personalized Risk, Risk Communication, Shared Decision Making, Screening Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 May 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 primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.
The secondary objectives:
- Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes;
- Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates.
The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of participants' risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to a participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.
This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.
Detailed description
Colorectal cancer (CRC) can be effectively prevented by screening. Risk to develop CRC within 15 years is related to increasing age, sex, family history, and lifestyle and, thus, can vary from <1% to >15%.
Fecal immunochemical test (FIT) and colonoscopy are the most widely used screening tests. Colonoscopy is the most accurate test, but is related to risks of bleeding and perforation. Colonoscopy resources are limited, and high uptake of screening colonoscopy for low-risk individuals can cause long wait times for those with CRC symptoms or positive FIT. FIT is less costly can be done at home without preparation and, if done regularly, prevents most CRC mortality, especially in moderate and low-risk individuals. To offer the screening options with a reasonable risk-benefit balance, FIT should be recommended to individuals at low (<3% to develop CRC in 15 years) and moderate (3-6%) risk, and colonoscopy to those at high (>6%) risk.
The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.
The secondary objectives:
- Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes;
- Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates.
The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of the participant's risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.
This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention brochureParticipants in the Intervention group receive a brochure with their personalized risk score for colorectal cancer and screening recommendations (FIT or colonoscopy) corresponding to their risk level. |
| Usual care group | Active comparator | Behavioral: Control brochureParticipants in the Usual care group receive the standard brochure designed by the Vaud screening program. This brochure recommends screening to all individuals beginning at age 50 and presents both FIT and colonoscopy as equal options. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 50 and 69;
- Residents of the Canton of Vaud;
- Have signed an informed consent (paper or electronic).
Key exclusion criteria (6 listed)
- Current CRC symptoms;
- Personal CRC history;
- In colonoscopy surveillance for follow-up of high-risk polyp(s);
- Inflammatory bowel disease;
- Having done a colonoscopy within 9 years or a FIT within 1,5 years;
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 |
|---|---|---|
| Intervention brochureProvide participants with information about their personalized risk for colorectal cancer and appropriate screening recommendations to facilitate their screening option choice. | Behavioural | Intervention group |
| Control brochureProvide participants with general information about options for colorectal cancer screening. | Behavioural | Usual care group |
Primary outcome
Self-reported appropriate screening uptake
Time frame: 6-8 months after the intervention
Proportion who completed screening test appropriate to risk level. For low risk (<3% 15-yr CRC risk), completing a FIT. For intermediate risk (3-6%15-yr CRC risk), completing a FIT, completing a colonoscopy, or having a colonoscopy appointment. For high risk (>6% 15-yr CRC risk), completing a colonoscopy or having a colonoscopy appointment.
6 secondary outcomes
Self-reported overall screening participation
Time frame: 6-8 months after the intervention
Participation in the randomized trial
Time frame: 6 weeks after mailed invitations
Eligibility for the Vaud CRC screening program
Time frame: 6 weeks after mailed invitations
Self-reported anxiety
Time frame: 6 weeks after mailed invitations
Linkage to Vaud CRC screening program
Time frame: 3-6 months after measurement of primary outcome
Linkage to Vaud tumor registry
Time frame: 6 months to 10 years after measurement of primary outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Background: PubMed 25783428Hippisley-Cox J, Coupland C. Development and validation of risk prediction algorithms to estimate future risk of common cancers in men and women: prospective cohort study. BMJ Open. 2015 Mar 17;5(3):e007825. doi: 10.1136/bmjopen-2015-007825.
- Background: PubMed 35353458Samusure J, Horisberger D, Diserens C, Ducros C, Auer R, Bodenmann P, Durand MA, Selby K. [Information materials for colorectal cancer screening for citizens with low health literacy]. Rev Med Suisse. 2022 Mar 30;18(775):616-620. doi: 10.53738/REVMED.2022.18.775.616. French.
- Background: PubMed 37676720Plys E, Bulliard JL, Chaouch A, Durand MA, van Duuren LA, Brandle K, Auer R, Froehlich F, Lansdorp-Vogelaar I, Corley DA, Selby K. Colorectal Cancer Screening Decision Based on Predicted Risk: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 7;12:e46865. doi: 10.2196/46865.
- Derived from this study: PubMed 39774118Plys E, Bulliard JL, Chaouch A, Durand MA, van Duuren LA, Braendle K, Auer R, Froehlich F, Lansdorp-Vogelaar I, Corley DA, Selby K. Colorectal Cancer Screening Based on Predicted Risk: A Randomized Controlled Trial. Am J Gastroenterol. 2025 Oct 1;120(10):2432-2439. doi: 10.14309/ajg.0000000000003311. Epub 2025 Jan 7.
- Risk calculator usedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon publication of the primary results, the data that support the findings of this study will be available from the corresponding author upon reasonable request.
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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.
Kevin Selby, MD, MAS principal investigator
Center for Primary Care and Public Health (Unisanté)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention brochure in people with Colorectal Cancer, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 16 May 2024. 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 Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported appropriate screening uptake (time frame: 6-8 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05357508, which also lists 4 linked publications.
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 16 May 2024.