Related Experiment Video
Updated: Feb 18, 2026
Cell-Free DNA Integrity Analysis in Urine Samples
Published on: January 5, 2017
DETECT I & DETECT II: a study protocol for a prospective multicentre observational study to validate the UroMark
Wei Shen Tan1,2, Andrew Feber3, Liqin Dong3
1Division of Surgery and Interventional Science, University College London, 74 Huntley Street, London, WC1E 6AU, UK. wei.tan@ucl.ac.uk.
Insights
A new urinary test, UroMark, shows promise for detecting bladder cancer and aiding surveillance for non-muscle invasive bladder cancer (NMIBC). This DNA-based assay could improve diagnostic pathways and reduce the need for invasive cystoscopies.
Area of Science:
- Oncology
- Urology
- Molecular Diagnostics
Background:
- Haematuria diagnosis and non-muscle invasive bladder cancer (NMIBC) surveillance often rely on invasive cystoscopy.
- Cystoscopy is uncomfortable, requires hospital visits, and carries a risk of urinary tract infections.
- The UroMark assay detects 150 methylation alterations specific to bladder cancer in urinary DNA.
Purpose of the Study:
- To validate the UroMark assay's performance in detecting bladder cancer.
- To assess UroMark's negative predictive value in ruling out bladder cancer in patients with haematuria.
- To evaluate UroMark's sensitivity in detecting various grades of bladder cancer and its utility in NMIBC surveillance.
Main Methods:
- Two multi-center prospective observational studies (DETECT I and DETECT II) were conducted.
- DETECT I assessed UroMark's ability to rule out bladder cancer in haematuria patients.
- DETECT II evaluated UroMark's sensitivity in new/recurrent bladder cancer and its use in NMIBC surveillance, comparing results to cystoscopy and histopathology.
Main Results:
- The UroMark assay utilizes next-generation sequencing to analyze 150 specific DNA methylation loci.
- A random forest classifier approach enhances assay sensitivity and addresses limitations of previous biomarker panels.
- Study results are compared against cystoscopy and histopathological findings for validation.
Conclusions:
- A sensitive and specific urinary biomarker like UroMark could revolutionize bladder cancer diagnostics and NMIBC surveillance.
- UroMark represents a significant advancement over existing urinary tests, many of which are not recommended as standalone diagnostics.
- The assay's technological approach offers improved sensitivity and addresses shortcomings of prior diagnostic methods.
Background:
Haematuria is a common finding in general practice which requires visual inspection of the bladder by cystoscopy as well as upper tract imaging. In addition, patients with non-muscle invasive bladder cancer (NMIBC) often require surveillance cystoscopy as often as three monthly depending on disease risk. However, cystoscopy is an invasive procedure which is uncomfortable, requires hospital attendance and is associated with a risk of urinary tract infection. We have developed the UroMark assay, which can detect 150 methylation specific alteration specific to bladder cancer using DNA from urinary sediment cells.
Methods:
DETECT I and DETECT II are two multi-centre prospective observational studies designed to conduct a robust validation of the UroMark assay. DETECT I will recruit patients having diagnostic investigations for haematuria to determine the negative predictive value of the UroMark to rule out the presence of bladder cancer. DETECT II will recruit patients with new or recurrent bladder cancer to determine the sensitivity of the UroMark in detecting low, intermediate and high grade bladder cancer. NMIBC patients in DETECT II will be followed up with three monthly urine sample collection for 24 months while having surveillance cystoscopy. DETECT II will include a qualitative analysis of semi-structured interviews to explore patients' experience of being diagnosed with bladder cancer and having cystoscopy and a urinary test for bladder cancer surveillance. Results of the UroMark will be compared to cystoscopy findings and histopathological results in patients with bladder cancer.
Discussion:
A sensitive and specific urinary biomarker will revolutionise the haematuria diagnostic pathway and surveillance strategies for NMIBC patients. None of the six approved US Food and Drug Administration urinary test are recommended as a standalone test. The UroMark assay is based on next generation sequencing technology which interrogates 150 loci and represents a step change compared to other biomarker panels. This enhances the sensitivity of the test and by using a random forest classifier approach, where the UroMark results are derived from a cut off generated from known outcomes of previous samples, addresses many shortcomings of previous assays.
Trial Registration:
Both trails are registered on clinicaltrials.gov.
Detect I:
NCT02676180 (18th December 2015).
Detect Ii:
NCT02781428 (11th May 2016).
More Related Videos
11:02Induction of Invasive Transitional Cell Bladder Carcinoma in Immune Intact Human MUC1 Transgenic Mice: A Model for Immunotherapy Development
Published on: October 30, 2013
08:43An Orthotopic Bladder Tumor Model and the Evaluation of Intravesical saRNA Treatment
Published on: July 28, 2012
