Aim To compare acceptability and diagnostic accuracy of a recently available faecal immunochemical test (FIT) system (HM-JACKarc) with the FIT routinely used in an established screening programme (OC-Sensor).
Design Randomised controlled trial (ISRCTN20086618) within a population-based colorectal cancer (CRC) screening programme. Subjects eligible for invitation in the Umbria Region (Italy) programme were randomised (ratio 1:1) to be screened using one of the FIT systems.
Results Screening uptake among the 48 888 invitees was the same for both systems among subjects invited in the first round and higher with OC-Sensor than with HM-JACKarc (relative risk (RR): 1.03; 95% CI 1.02 to 1.04) among those invited in subsequent rounds. Positivity rate (PR) was similar with OC-Sensor (6.5%) as with HM-JACKarc (6.2%) among subjects performing their first FIT screening and higher with OC-Sensor (5.6%, RR: 1.25, 95% CI 1.12 to 1.40) than with HM-JACKarc (4.4%) among those screened in previous rounds. Positive predictive value (PPV) (OC-Sensor: 25.9%, HM-JACKarc: 25.6%) and detection rate (DR) (OC-Sensor: 1.40%; HM-JACKarc: 1.42%) for advanced neoplasia (AN: CRC + advanced adenoma) were similar among subjects performing their first FIT screening. The differences in the AN PPV (OC-Sensor: 20.3%, HM-JACKarc: 22.6%) and DR (OC-Sensor: 0.96%, HM-JACKarc: 0.83%) among those screened in previous rounds were not statistically significant. The number needed to scope to detect one AN was 3.9 (95% CI 5.8 to 2.9) and 3.9 (95% CI 5.5 to 2.9) at first and 4.9 (95% CI 5.8 to 4.2) and 4.4 (95% CI 5.3 to 3.7) at subsequent screening, with OC-Sensor and HM-JACKarc, respectively.
Conclusions Our results suggest that acceptability and diagnostic performance of HM-JACKarc and of OC-Sensor systems are similar in a screening setting.
Trial registration number ISRCTN20086618; Results.
- CANCER PREVENTION
- COLORECTAL CANCER SCREENING
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Contributors BP, MM, MG TR, CS conceived the idea for this work. MM collated the data; CS, MM, CF contributed to the data analysis. CS, MM, CF, NS, wrote drafts of the manuscript. BT, AC, VD'A, PG, EDD performed laboratory tests, LM organised invitations, SB, MRD'A, DG, NM, NS, EC participated in the planning of the study. All authors critically reviewed the submitted manuscript and gave important intellectual input. All authors approved the final version of the manuscript.
Funding The study was funded by the Umbria Regional Health Authority Kyowa Medex and Menarini provided the faecal immunochemical test used in the study.
Competing interests CGF has undertaken paid consultancy with Immunostics and Kyowa Medex, and received funding for attendance at meetings from Alpha Labs. CS (past 2 years): received support by Medical System for travel and accommodation at a scientific meeting in Italy. His Institution receives PillCam Colon devices from Covidien-Given Imaging to conduct a study and, during 2014, it has received without charge, from EndoChoice, Fuse endoscopy systems to conduct a trial.
Patient consent Obtained.
Ethics approval The study was approved by the local Ethics Review Board Prot. n.3032/14/AV 29/04/2014.
Provenance and peer review Not commissioned; externally peer reviewed.