The Correlates of Kidney Dysfunction – Tumour Nephrectomy Database (CKD-TUNED) Study: Protocol for a Prospective Observational Study

Background: Tumour nephrectomy conveys a significant risk of adverse renal functional outcomes postoperatively, however there are limited strategies for predicting patients at increased risk of these outcomes. The Correlates of Kidney Dysfunction – Tumour Nephrectomy Database (CKD-TUNED) study is a prospective observational study evaluating the risk of chronic kidney disease and end-stage kidney disease in tumour nephrectomy patients. Methods: The CKDTUNED study involves analysis of clinical data and collection of tissue, urine and blood samples for the purposes of forming a tissue repository resource for future investigation. Recruitment began in 2013 and is expected to continue until 2023, with a projected sample size between 700-1000 subjects. Results: All relevant ethics and site-specific approvals have been granted and all relevant infrastructure is in place. Study methods are undergoing validation and refinement. As of June 2017 there are 267 participants enrolled in the study. Conclusion: It is anticipated that this study will have the potential to identify risk factors for adverse renal functional outcomes following tumour nephrectomy, which can be used in the development of predictive models with clinical utility, and in turn improve patient outcomes.