Haematuria Signs and Symptoms Unspecified haematuria
Conditions
Interventions
At the clinic the Research Nurse will record height, weight and blood pressure, medical history and ask questions about lifestyle and occupations before collecting one urine and one blood sample. The
Sponsors
Queen?s University Belfast (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Bladder cancer patients Patients with pathologically proven bladder cancer, newly diagnosed or recurrent, will be recruited prior to transurethral resection of the bladder tumour at pre-assessment clinics, as in-patients on urology wards or at planned cystoscopy sessions. 1. Written informed consent to participate in the study 2. Aged between 40 and 80 years 3. Current haematuria or a history of haematuria 4. Cystoscopy within the last 6 months or planned cystoscopy 5. No chemo- or radio- therapy in the three weeks prior to recruitment 6. No previous history of cancers other than bladder cancer 7. Suspicion of bladder cancer or proven bladder cancer Control patients These patients will be recruited from haematuria clinics following negative cystoscopy and negative findings for other bladder cancer investigations. 1. Written informed consent to participate in the study 2. No previous history of cancer 3. Of the same gender, approximate age and smoking status (where possible) to a bladder cancer patient already recruited to HaBio 4. Current haematuria or a history of haematuria 5. Negative cystoscopy within the last 3 months, but at least 48h after the procedure 6. No chemo- or radio- therapy in the three weeks prior to recruitment
Exclusion criteria
Exclusion criteria: Bladder cancer patients: 1. No written informed consent to participate in the study 2. Aged 85 years 3. No history of haematuria 4. No recent or planned cystoscopy 5. Chemo- or radio- therapy in the three weeks prior to recruitment 6. Previous history of cancer(s), other than bladder cancer 7. No suspicion of bladder cancer or proven bladder cancer Control patients: 1. No written informed consent to participate in the study 2. Previous history of any cancer 3. Not of the same gender, approximate age and smoking status of a patients already recruited as a bladder cancer patient 4. No history of haematuria 5. No recent or planned cystoscopy 6. Chemo- or radio- therapy in the three weeks prior to recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 r | — |
Countries
England, Northern Ireland, United Kingdom
Outcome results
None listed