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Background: Colonoscopy screening is underused by first-degree relatives (FDRs) of patients with non-syndromic colorectal cancer (CRC) with screening completion rates below 50%. Studies conducted in FDR referred for screening suggest that fecal immunochemical testing (FIT) was not inferior to colonoscopy in terms of diagnostic yield and tumor staging, but screening uptake of FIT has not yet been tested in this population. In this study, we investigated whether the uptake of FIT screening is superior to the uptake of colonoscopy screening in the familial-risk population, with an equivalent effect on CRC detection. Methods and findings: This open-label, parallel-group, randomized trial was conducted in 12 Spanish centers between February 2016 and December 2021. Eligible individuals included asymptomatic FDR of index cases <60 years, siblings or ≥2 FDR with CRC. The primary outcome was to compare screening uptake between colonoscopy and FIT. The secondary outcome was to determine the efficacy of each strategy to detect advanced colorectal neoplasia (adenoma or serrated polyps ≥10 mm, polyps with tubulovillous architecture, high-grade dysplasia, and/or CRC). Screening-naïve FDR were randomized (1:1) to one-time colonoscopy versus annual FIT during 3 consecutive years followed by a work-up colonoscopy in the case of a positive test. Randomization was performed before signing the informed consent using computer-generated allocation algorithm based on stratified block randomization. Multivariable regression analysis was performed by intention-to-screen. On December 31, 2019, when 81% of the estimated sample size was reached, the trial was terminated prematurely after an interim analysis for futility. Study outcomes were further analyzed through 2-year follow-up. The main limitation of this study was the impossibility of collecting information on eligible individuals who declined to participate. A total of 1,790 FDR of 460 index cases were evaluated for inclusion, of whom 870 were assigned to undergo one-time colonoscopy (n = 431) or FIT (n = 439). Of them, 383 (44.0%) attended the appointment and signed the informed consent: 147/431 (34.1%) FDR received colonoscopy-based screening and 158/439 (35.9%) underwent FIT-based screening (odds ratio [OR] 1.08; 95% confidence intervals [CI] [0.82, 1.44], p = 0.564). The detection rate of advanced colorectal neoplasia was significantly higher in the colonoscopy group than in the FIT group (OR 3.64, 95% CI [1.55, 8.53], p = 0.003). Study outcomes did not change throughout follow-up. Conclusions: In this study, compared to colonoscopy, FIT screening did not improve screening uptake by individuals at high risk of CRC, resulting in less detection of advanced colorectal neoplasia. Further studies are needed to assess how screening uptake could be improved in this high-risk group, including by inclusion in population-based screening programs. Trial registration: This trial was registered with ClinicalTrials.gov (NCT02567045). In a randomized trial Natalia González-López and co-workers investigate whether fecal immunochemical testing improves screening uptake in first degree relatives of patients with non-syndromic colorectal cancer. Author summary: Why was this study done?: The risk of colorectal cancer (CRC) is 3 to 4 times higher in first-degree relative (FDR) of patients with non-syndromic CRC. These individuals are considered candidates for colonoscopy-based screening starting at 40 years of age, but this approach is associated with a suboptimal acceptance rate of approximately 50%. Recent evidence suggests that annual fecal immunochemical testing (FIT) may be equivalent to colonoscopy for detecting CRC and advanced adenomas, but the acceptance of this strategy is unknown in the familial-risk population. This study was designed to test the hypothesis that the uptake of FIT screening is superior to the uptake of colonoscopy screening in this population, with an equivalent effect on CRC detection. What did the researchers do and find?: This multicenter randomized controlled trial included 870 asymptomatic FDR of patients with non-syndromic CRC. Participants were invited to participate through their affected index case(s). FDR were randomized (1:1) to one-time colonoscopy versus annual FIT during 3 consecutive years followed by a work-up colonoscopy in the case of a positive test. The rate of screening completion was similar in the group assigned to FIT and the group assigned to colonoscopy screening (36% versus 34%, respectively). The detection rate of advanced colorectal neoplasia was significantly lower in subjects receiving annual FIT than in those assigned to receive one-time colonoscopy. What do these findings mean?: The findings of this trial indicate that FIT does not have the capacity of increasing the acceptance of screening in the non-syndromic familial CRC population. The fact that over 50% of eligible individuals refused to participate indicates that novel educational measures should be implemented to improve the awareness of individuals at risk and their providers. Future studies are needed to assess whether screening uptake can be improved for these individuals through their inclusion in population-based screening programs or by offering a choice between FIT and colonoscopy screening. The main limitation of this study was that it was not possible to collect information on eligible individuals who declined to participate, thus impeding our understanding behind low screening uptake in this population. [ABSTRACT FROM AUTHOR]