Haematuria Biomarker Study (HaBio)

Single biomarkers and/or multivariate algorithms will significantly improve on the predictive power of an algorithm based on demographics for prediction of causes of haematuria in patients presenting with haematuria.

1. Patient age, gender, current medications, date of cystoscopy and date of initial diagnosis of bladder cancer (if relevant) are recorded from the patient notes by a Clinical Research Nurse (CRN) or the HaBio clinician at the time of recruitment
2. Blood pressure and body mass index (BMI) measurements, together with dip-stick analyses are undertaken by the CRN or the HaBio clinician at the time of recruitment
3. A detailed history of smoking, cancers, hypertension, renal stones, pelvic irradiation, and urinary tract infections; weekly alcohol consumption; present and past occupations; lower urinary symptoms; and whether the patient presented with visible or non-visible haematuria are recorded by the CRN or the HaBio clinician following discussion with each patient at their time of recruitment
4. Urine and blood samples are obtained from each patient by the CRN or the HaBio clinician at the time of recruitment
5. Scientists complete analyses of ~ 60 biomarker levels for each patient at Randox Laboratories Ltd (Country Antrim, Northern Ireland) as soon as possible after recruitment
6. Investigation results, details of positive micro-organism findings, causes of infection, causes of benign disease and levels of clinical biomarkers are recorded following review of the patient notes by a consultant urologist at least six weeks after recruitment
7. One or more causes of haematuria are recorded for each patient following review of the patient notes by a consultant urologist at least six weeks after recruitment
8. Where applicable, cause of death, details of chronic kidney disease, non-urological cancers, biomarkers measured in NHS, bladder cancer treatments, prostate and kidney pathology are recorded following review of the patient notes by the HaBio Clinician at the time of follow up
9. Where applicable, pathological review to obtain dates of recurrences and progression and pathology reports for tissue removed at the time of recruitment are recorded for all patients following review of the patient notes by the HaBio Clinician at the time of follow up
10. A detailed pathological review including details of pathological variants is completed by a consultant pathologist following completion of follow up
11. Patterns of expression and cell type location of key biomarkers using appropriate immunohistochemistry (IHC) on sections from diagnostic bladder tissue samples from patients is completed for each patient after completion of the diagnostic review by a Consultant Pathologist