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NCT05357508Completed

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 · Last updated 16 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
515 (actual)
First submitted
19 Apr 2022
Start date
1 May 2022
Primary completion date
31 Jul 2023
Lead sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
NCT number
NCT05357508

What you commit to

  • Study type: Interventional
  • Participants enrolled: 515
  • From 1 May 2022 to the primary completion date, 31 Jul 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Inflammatory bowel disease;

Other

  • Current CRC symptoms;
  • Personal CRC history;
  • In colonoscopy surveillance for follow-up of high-risk polyp(s);
  • Having done a colonoscopy within 9 years or a FIT within 1,5 years;
  • Planning to leave Switzerland definitively within the next six months.

Who the study is looking for

  • Aged between 50 and 69;
  • Residents of the Canton of Vaud;
  • Have signed an informed consent (paper or electronic).

Age in the registry: 50 years to 69 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Center for Primary Care and Public Health (Unisante)
Coordinator of this site? Confirm its status
LausanneSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.