The Haematuria Biomarker (HaBio) Study is a three-way collaborative project between Queen's University Belfast, Northern Ireland Health Trusts and Randox Laboratories Ltd, an international clinical diagnostics company. HaBio is funded by Invest Northern Ireland (INI). The Chief Investigator, Dr Kate Williamson, Queen's University Belfast has obtained ethical approval from the Office of Research Ethics Committee Northern Ireland (11/NI/0164) to recruit 999 patients who satisfy the HaBio study inclusion criteria. A Research Nurse or Doctor will measure each patient’s height, weight and blood pressure and will record details about medical history, lifestyle and occupations before collecting one urine and one blood sample. The protocol for HaBio was also reviewed by hospital review boards and will be conducted according to the standards for reporting of diagnostic accuracy guidelines (Bossuyt, 2003).
The aim of HaBio is to identify collectives of protein biomarkers that can act as diagnostic classifiers for patients with haematuria. Biomarkers are objectively measured indicators of a disease state. This approach will avoid invasive tests and will pick up serious diseases earlier.
A classifier can be defined as a step-by step method of solving a problem. In the context of HaBio, a diagnostic classifier is a mathematical equation which describes the relationship between biomarkers that distinguish patients with bladder cancer from those who do not have bladder cancer. The biomarkers which contribute to the classifier(s) will be defined following analysis of the data collected during HaBio.