Clinical trial · Interventional
Colorectal Cancer Screening Based on Predicted Risk
Protocol Title: Colorectal Cancer Screening Decisions Based on Predicted Risk: the PREcision ScreENing Randomized Controlled Trial (PRESENT)
- 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 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.
Conditions
Conditions (1)
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control brochure | Behavioral | — | UNRESOLVED |
| Intervention brochure | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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.
- interventionNames
- Behavioral: Intervention brochure
- type
- ACTIVE_COMPARATOR
- label
- Usual care group
- description
- 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.
- interventionNames
- Behavioral: Control brochure
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Aged between 50 and 69; * Residents of the Canton of Vaud; * Have signed an informed consent (paper or electronic). Exclusion Criteria: * 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.
References
Publications (4)
- BACKGROUNDHippisley-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. PMID 25783428
- BACKGROUNDSamusure 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. PMID 35353458
- BACKGROUNDPlys 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. PMID 37676720
- DERIVEDPlys 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. PMID 39774118