Blood in urine
The number of patients who have blood in their urine and the number of bladder cancer patients is increasing. This is partly because most people are living longer. However, not all patients with blood in their urine are old.
Blood in urine can be a sign of many diseases and sometimes no cause for blood in urine is identified. Everyone who reports blood in their urine should have tests at a hospital. This places an enormous burden on Healthcare resources. Therefore doctors urgently need new ways to identify which patients presenting with blood in their urine are at greatest risk of bladder cancer.
Who is involved in HaBio?
This study is a three-way collaboration between Queen's University Belfast, Northern Ireland Health Trusts and a Northern Ireland based industrial partner, Randox Laboratories Ltd.
What will the investigators be doing?
This study will recruit a total of 999 patients who have blood in their urine. We will record details about each patient's medical history, occupation, and their lifestyle. The information will be carefully stored in a specialised, secure database within the Northern Ireland Cancer Trials Centre. We will collect urine and blood samples from all the patients. Randox Laboratories will screen for approximately 60 proteins in either blood or urine from each patient. Randox will not be given any information which could identify any patient recruited to the study.
What will happen to patients when they are recruited?
HaBio patients will be asked to sign a consent form, of which they will be given a copy. Clinical Research Nurses will inform GPs when their patients have consented to take part in HaBio. A Clinical Research Nurse will record the patient's height, weight, blood pressure, medical history and ask questions about their lifestyle and occupations before collecting a urine and blood sample. You will be asked to provide approximately 25ml sample of urine (5 teaspoons) and approximately 35ml sample of blood (7 teaspoons). If the doctor removes bladder tissue removed during the surgical procedure the researchers will review the tissue and use small samples to identify protein, DNA and RNA. Your patient notes will be reviewed by members of the HaBio clinical team. The HaBio clinical team will inform your consultant of their review findings should this be appropriate. This may be beneficial for you. Members of the HaBio clinical team will review your notes for a second time 3 years after recruitment to obtain information about your health.
How will we analyse the information we collect?
All the information collected will be anonymised prior to analyses using classical and advanced statistical approaches. For our analysis, we will apply classical statistical methods which will be complemented by novel statistical and computational methods to extract reliable and robust information from the experimental data. We will establish panels of proteins that can accurately diagnose the cause of most patients' haematuria. Randox Laboratories will then manufacture biochips which will be used to detect these proteins simultaneously. Measurement of the proteins will be converted to a score which will be interpreted by the patient's doctor. The information will help the doctor to decide how best to help the patient.
Data at all times will be stored securely in accordance with the procedures of the Northern Ireland Cancer Trials Centre and Queen's University Belfast.