One-Time Faecal Immunochemical Screening for Advanced Colorectal Neoplasia in Patients with Chronic Kidney Disease (Detect Study)

Background: Screening for advanced colorectal neoplasia by faecal immunochemical testing (FIT) reduces mortality from colorectal cancer in the general population. People with chronic kidney disease (CKD) are at higher risk of colorectal cancer and their prognosis is poorer, but the test performance characteristics, positivity and detection rates of this strategy in this setting are unknown. Methods: From May 2010 to November 2015, 1706 patients with CKD [stages III-V, dialysis and transplant, aged 35-74 years] across eleven sites in Australia, New Zealand, Canada and Spain were prospectively screened using FIT. A two-step reference standard approach (work-up colonoscopies for those with positive FIT and two-year follow-up for all participants) was used to estimate disease status. Findings: Overall, 369 (21·6%) tested positive, of whom 323 (87·5%) underwent colonoscopies, and 1553 (91·0%) completed two-year follow-up (82 (4·8%) died and 71 (4·2%) were lost). The detection rate of advanced colorectal neoplasia using FIT was 6·0% (CKD III-V, 5·6%; dialysis, 7·2%; transplant recipients, 5·6%). Sensitivity, specificity, positive and negative predictive values (95% confidence intervals) of FIT for advanced colorectal neoplasia were 0·90 (0·84 - 0·95), 0·83 (0·81 - 0·85), 0·30 (0·25 - 0·35) and 0·99 (0·98 - 1·00), respectively. Approximately 1·5% experienced major colonoscopy-related complications including bowel perforation (1, 0·3%), peritonitis (2, 0·6%), and bleeding (2, 0·6%). Interpretation: The positivity and advanced neoplasia detection rates of one-time FIT screening in patients with CKD are high, with favourable test performance characteristics, such that a negative test may preclude the diagnosis of colorectal cancer within two years. Funding: The Australian National Health and Medical Research Council Screening and Test Evaluation Program Grant (APP 633003) and BEAT-CKD Program Grant (APP 1092579) Declaration of Interest: No authors have any financial relationships with any organisations that might have any interests in the submitted work, and no other relationships or activities that may have influenced the conduct of the submitted work. Ethical Approval: This study was approved by the Human and Research Ethics Committee (HREC) of all participating centres (Westmead, Gosford, Royal North Shore, Blacktown, Nepean, Sir Charles Gairdner, Concord, Royal Prince Alfred, Toronto General, and Christchurch Hospitals, and the Hospital Clinic of Barcelona).