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Personalized colorectal cancer screening: a randomized trial

PREcision ScrEeniNg for ColoRectal Cancer: a Randomized Non-inferiority Trial (PRESENT-CRC)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10525659
Enrollment
8050
Registered
2025-10-27
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer screening Cancer

Interventions

The trial statistician calculated a randomization plan with varying block sizes and implemented it in the REDCap randomization module. Intervention 1: Risk-based screening recommendations. Participan

Sponsors

Centre universitaire de médecine générale et santé publique, Lausanne
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 50 and 74 years old 2. Residing in a canton whose screening center is recruiting for the trial 3. Having provided informed consent

Exclusion criteria

Exclusion criteria: People at very high risk of CRC or already up to date with screening are excluded. Specifically, those: 1. With current symptoms suspicious for colorectal cancer (i.e. rectal bleeding, unusual weight loss, etc.) 2. With a medical condition requiring colonoscopy surveillance at a shorter than 10-year interval 3. Having had a colonoscopy within 9.5 years or a FIT within 1.5 years

Design outcomes

Primary

MeasureTime frame
Advanced colorectal neoplasia, defined as the proportion of participants with at least 1 of the following: adenoma > 1 cm; adenoma of any size with high-grade dysplasia; adenoma with villous or tubulovillous histology (=25% villous); serrated lesion > 1 cm; serrated lesion of any size with high-grade dysplasia; traditional serrated adenoma (any size); and, adenocarcinoma, measured using data collected from patient medical records, at 3-year follow-up

Secondary

MeasureTime frame
Secondary outcome measures are assessed using data collected from patient medical records: 1. Colonoscopy completion among high-risk participants, defined as the proportion of participants with at least one colonoscopy recorded by the organized screening program, at 1-year follow-up 2. Fecal immunochemical test (FIT) completion among low-risk participants, defined as the proportion of participants with at least one FIT result recorded by the colorectal cancer screening program, at 1-year follow-up 3. Overall screening participation, defined as the proportion of participants with at least one colonoscopy or one FIT recorded by the colorectal cancer screening program, at 1-year follow-up 4. Number needed to scope, defined as the number of colonoscopies performed per advanced neoplasia detected, at 3-year follow-up 5. Overall screening participation by socioeconomic status at 1-year follow-up. This outcome will be calculated in the same way as overall screening participation. Comparisons will be stratified by deciles of the Swiss Socio-Economic Position (Swiss-SEP) score, an address-based, area-level index, to assess whether the intervention's effect on participation varies by socioeconomic position.

Countries

Switzerland

Contacts

Public ContactKevin Selby
kevin.selby@unisante.ch+41213146061

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026