NCT05357508: PRESENT

Colorectal Cancer Screening Based on Predicted Risk

Completed NA Last updated 16 May 2024

What this trial tests

NA trial testing Intervention brochure in Colorectal Cancer in 515 participants. Completed in 31 December 2023.

Timeline

1 May 2022

Primary endpoint
31 July 2023

31 December 2023

Quick facts

Lead sponsor	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	515
Start date	1 May 2022
Primary completion	31 July 2023
Estimated completion	31 December 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• Intervention brochure
• Control brochure

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Who can join

Adults 50 to 69, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Colorectal Cancer Screening Decision Based on Predicted Risk: Protocol for a Pilot Randomized Controlled Trial.
   Plys E, Bulliard JL, Chaouch A, Durand MA, et al · · 2023 · cited 4× · PMID 37676720 · DOI 10.2196/46865
2. Current Progress in Clinical Research in Secondary Prevention and Early Detection of Colorectal Cancer.
   Partyka O, Pajewska M, Czerw A, Deptała A, et al · · 2025 · cited 2× · PMID 39941735 · DOI 10.3390/cancers17030367
3. Colorectal Cancer Screening Based on Predicted Risk: A Randomized Controlled Trial.
   Plys E, Bulliard JL, Chaouch A, Durand MA, et al · · 2025 · cited 1× · PMID 39774118 · DOI 10.14309/ajg.0000000000003311
4. Colorectal cancer screening based on predicted risk: a pilot randomized controlled trial
   Plys E, Bulliard J, Chaouch A, Durand M, et al · · 2024 · DOI 10.1101/2024.03.15.24304344