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Project

Development of the UroMark assay. A non-invasive test for the detection of bladder cancer in urinary sediment cells

Funder: Medical Research Council

Funding period
GBP 1.4 M
USD 2.2 M
Funding amount
Abstract
Investigation for bladder cancer in patients with blood in their urine (haematuria) is important and incurs a cost to UK healthcare estimated at £55.39 million per year ranking bladder as one of the most expensive cancers to manage. Although haematuria is a sign of bladder cancer only 10% of patients with haematuria will be found to have cancer. In the majority of instances a non cancer cause and frequently no cause is found. The assessment of haematuria involves passing an instrument along the urethra, or water pipe, to view the lining of the bladder wall. The assessment known as cystoscopy is uncomfortable, carries a low but significant risk of infection and requires referral from a GP to hospital. We have developed a test which uses cutting edge technology known as highly multiplexed targeted sequencing to detect cancer specific changes known as epigenetic alterations in cells which can be collected from urine. A urine sample for testing can be provided at home and sent to our lab using the postal system. The test, UroMark, utilises a platform known as RainDrop BS-Seq to analyse a panel of 150 epigenetic alterations which accurately discriminate between bladder cancer and normal. In proof of concept studies the test performs with high sensitivity and specificity for the detection of bladder cancer.

The incorporation of a highly sensitive and specific assay will revolutionise bladder cancer pathways, have a profound impact on the requirement for cystoscopy and on patient wellbeing and, reduce the healthcare costs associated with investigation of haematuria and surveillance for disease recurrence.

Technical Summary
Cystoscopic investigation for bladder cancer in patients with haematuria and in patients requiring surveillance for recurrent disease incurs a cost to UK healthcare estimated at £55.39 million per year ranking bladder as one of the most expensive cancers to manage. We have developed a highly multiplexed targeted sequencing assay (UroMark) to detect cancer specific epigenetic alterations in urinary sediment, along with a home collection kit allowing the collection of urine through the postal system. The UroMark assay utilises a micro-droplet PCR platform (RainDance Technology) which allows the analysis of a panel of 150 epigenetically altered loci which accurately discriminate between tumour and normal urothelium. Proof of concept testing has shown the potential utility of this assay for the detection of bladder cancer in urinary sediment cells. The aim this project is to validate the UroMark assay through two non-IMP clinical trials. DETECT I, will determine if the assay can rule out bladder cancer in patients with haematuria and DETECT II will validate the diagnostic accuracy of the test in a cohort trial enriched for low grade cancer. Our aim is to show sufficient diagnostic precision to replace cystoscopy in the evaluation of patients with haematuria. The incorporation of a highly sensitive and specific assay will revolutionise bladder cancer pathways, have a profound impact on the requirement for cystoscopy and on patient well being and, reduce the healthcare costs associated with investigation of haematuria and surveillance for disease recurrence.
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System

Categories
  • FOR (ANZSRC)

    1112 Oncology and Carcinogenesis

  • RCDC

    Cancer

  • RCDC

    Clinical Research

  • RCDC

    Urologic Diseases

  • HRCS HC

    Cancer

  • HRCS RAC

    4.1 Discovery and preclinical testing of markers and technologies

  • HRCS RAC

    4.2 Evaluation of markers and technologies

  • Health Research Areas

    Clinical

  • Broad Research Areas

    Clinical Medicine and Science