BACKGROUND: Colorectal cancer (CRC) incidence and mortality have declined among
older adults (age > 50 years), principally due to the implementation of screening. In
contrast, the incidence and mortality of CRC diagnosed before the age of 50, also known
as early onset CRC (eoCRC), are increasing in several high-income countries across the
globe, with the largest absolute increase among the 40–49 year-old group. Patients with
eoCRC tend to present with a more-advanced stage and a less favourable prognosis.
Although the American Cancer Society recommends screening from 45 years of age, this
screening strategy is still not offered in Europe. Screening starting at the age of 40 may
thus be a robust option to curb these worrisome trends.
OBJECTIVE: The main objective of this study is to assess If early screening using biennial
faecal immunochemical test (FIT) strategy reduces eoCRC mortality at 5 years in 40–49-
year-old men and women from the general population. Secondary objectives aim to
evaluate screening results and complications, to assess eoCRC risk factors, and compare
the quality of life between screened and unscreened patients with eoCRC.
DESIGN AND SETTING: This study was designed as a population-based, randomized,
parallel, group, open field trial, aiming to compare screening vs not screening strategies.
It will be a multicentric study conducted in the Primary Care Centres and 8 Hospitals of
the Health Region of Girona.
METHODS: 20,236 participants will be enrolled using a consecutive sampling, the time
of recruitment will be of 1 year. Participants will be randomised into two groups: 1)
undergoing screening with biennial FIT followed by colonoscopy in case of a positive
result, 2) not undergoing screening. The intervention will last for 4 years, and those
patients diagnosed with CRC during the study will be followed for 5 years after the
diagnosis. Major outcome variable will be CRC mortality at 5 years
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