Test performance of faecal occult blood testing for the detection of bowel cancer in people with chronic kidney disease (DETECT) protocol

Abstract

Background: Cancer is a major cause of mortality and morbidity in patients with chronic kidney disease (CKD). In patients without kidney disease, screening is a major strategy for reducing the risk of cancer and improving the health outcomes for those who developed cancers by detecting treatable cancers at an early stage. Among those with CKD, the effectiveness, the efficacy and patients' preferences for cancer screening are unknown. Methods/Design: This work describes the protocol for the DETECT study examining the effectiveness, efficiency and patient's perspectives of colorectal cancer screening using immunochemical faecal occult blood testing (iFOBT) for people with CKD. The aims of the DETECT study are 1) to determine the test performance characteristics of iFOBT screening in individuals with CKD, 2) to estimate the incremental costs and health benefits of iFOBT screening in CKD compared to no screening and 3) to elicit patients' perspective for colorectal cancer screening in the CKD population. Three different study designs will be used to explore the uncertainties surrounding colorectal cancer screening in CKD. A diagnostic test accuracy study of iFOBT screening will be conducted across all stages of CKD in patients ages 35-70. Using individually collected direct healthcare costs and outcomes from the diagnostic test accuracy study, cost-utility and cost-effective analyses will be performed to estimate the costs and health benefits of iFOBT screening in CKD. Qualitative in-depth interviews will be undertaken in a subset of participants from the diagnostic test accuracy study to investigate the perspectives, experiences, attitudes and beliefs about colorectal cancer screening among individuals with CKD. Discussion: The DETECT study will target the three major unknowns about early cancer detection in CKD. Findings from our study will provide accurate and definitive estimates of screening efficacy and efficiency for colorectal cancer, and will allow better service planning and budgeting for early cancer detection in this at-risk population. The DETECT study is also registered with the Australia New Zealand Clinical Trials Registry ACTRN12611000538943

Health-Related Quality of Life in People Across the Spectrum of CKD

“…The study protocol 9 was approved by the Human and Research Ethics Committee of all participating centers (Westmead, Gosford, Royal North Shore, Blacktown, Nepean, Sir Charles Gairdner, Concord, Royal Prince Alfred, Toronto General, Christchurch Hospitals, and the Hospital Clinic of Barcelona). All participants provided written informed consent.…”

Beliefs and Attitudes to Bowel Cancer Screening in Patients with CKD: A Semistructured Interview Study

“…The effects of bowel cancer screening are well established in the general population, but the benefits and harms of screening in CKD are largely unknown (6)(7)(8)(9)(10)(11)(12). Patients on dialysis are susceptible to gastrointestinal bleeding due to inflammation of the mucosa, anticoagulation use, and reduced platelet function as a result of uremia; thus, screening may lead to false positive results, requiring follow-up with colonoscopy.…”

One-Time Fecal Immunochemical Screening for Advanced Colorectal Neoplasia in Patients with CKD (DETECT Study)

“…Baseline recruitment was completed in December 2015 and the last work-up colonoscopy was carried out in April 2016. The study protocol 16 was approved by the Human and Research Ethics Committee of all participating centers (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). All participants provided written informed consent.…”

“…1 Sydney School of Public Health, Faculty of Medicine and Health, 19 School of Mathematics and Statistics, and 17 Charles Perkins Centre, The University of Sydney, Sydney, Australia; 2 Centre for Transplant and Renal Research, and 4 Department of Gastroenterology, Westmead Hospital, Westmead, New South Wales, Australia; 5 Gastroenterology Department, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain; 8 Department of Renal Medicine, Gosford Hospital, Gosford, Australia; 10 Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia; 11 Faculty of Medicine, University of Toronto, Ontario, Canada; 12 Department of Nephrology and Kidney Transplantation, Clinical and Provincial Hospital of Barcelona, Barcelona, Spain; 13 Department of Nephrology and Kidney Transplantation, Christchurch Hospital, Christchurch, New Zealand; 15 Department of Renal Medicine, Concord Repatriation General Hospital, Concord, Australia; 16 Department of Renal Medicine, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; 18…”