Prevalence of haematuria and its association with risk of urinary tract cancer: a case-control study using real-world data from UK primary care

Study type
Protocol
Date of Approval
Study reference ID
20_151
Lay Summary

Blood in the urine (haematuria) is the most common symptom to suggest that a patient may have urinary tract cancer, although it is also a common sign for many other conditions affecting the urinary system including infections and kidney stones. Cancer is a disease where in many cases symptoms are not apparent in the early stages of the disease, where identifying it at that point would mean treatment has more of a chance to be successful- the earlier a cancer can be detected, the better the chances of survival are. Therefore, identifying and researching early symptoms of urinary tract cancer could lead to improvements in survival. In this study we are going to compare patients with and without cancer to understand whether haematuria impacts the risk of developing urinary tract cancer. We will also investigate whether the impact of haematuria on the risk of cancer is impacted by sex and other patient characteristics. These results have the potential to be used to improve the detection of patients at risk of urinary tract cancer.

Technical Summary

Haematuria is the most common symptom for urinary tract cancer, particularly in those aged ? 60 years old and where the haematuria has developed without obvious explanation. In most instances of cancer, symptoms are not very apparent until a later stage of the disease, where survival outcomes are impacted by delays in diagnosis of the disease. Having an easily identifiable symptom such as haematuria for urinary tract cancer may result in earlier diagnosis and thus improved survival.

In this retrospective case control study patients who developed urinary tract cancer will be matched to similar patients based on age, sex and GP practice; and the frequency of occurrence of haematuria preceding urinary tract cancer will be investigated with conditional logistic regression.

This study will quantify the strength of association between haematuria and urinary tract cancer, and further analyses will also be performed to determine whether the association is modified by sex (females have been shown to have poorer survival outcomes than males urinary tract cancer patients). Furthermore, we will also investigate survival in urinary tract cancer patients (whilst taking into consideration potential confounding factors), and the average time between a patient developing haematuria and then going on to develop urinary tract cancer.

Together, this information will add to the evidence base on the prognostic value of haematuria in the diagnosis of urinary tract cancer in primary care.

Health Outcomes to be Measured

The primary outcome of this study is urinary tract cancer as defined by codes in Table 1 of Appendix A. In addition overall survival following urinary tract cancer diagnosis will be an exploratory outcome.

Collaborators

Robert Carroll - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Alex Simpson - Corresponding Applicant - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Sanket Parmanick - Collaborator - Mu SIgma