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Detecting Bladder Cancer Using the UroMark Test. (DETECT I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02676180
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : April 17, 2019
Information provided by (Responsible Party):
University College, London

Brief Summary:
DETECT I is a prospective multicentre observational diagnostic study to assess the performance of the UroMark assay to rule out bladder cancer in patients with haematuria. The study will recruit consecutive patients attending haematuria clinics as well as patients referred to urology outpatient clinics for investigation of haematuria. Consenting patients will be provided with a urine sample collection kit and asked to provide a urine sample. An additional urine sample for control assay testing will be provided after the clinic attendance.

Condition or disease Intervention/treatment
Bladder Cancer Other: Group

Detailed Description:

Transitional cell carcinoma (TCC) of the urinary bladder is responsible for >12,000 new cases of cancer and >5,000 deaths per year in England and Wales. Most bladder cancers are non-muscle invasive bladder cancer (NMIBC) and do not invade deeply at presentation, but 80% of tumours recur within 3 years. For muscle invasive bladder cancer (MIBC), the 5 year survival is around 50%. Cystoscopy is the standard test for detection of bladder cancer along with imaging to assess the upper tracts and the common presenting symptom is haematuria. Cystoscopy is an invasive procedure and results in urinary infection in up to 5% of cases. Cystoscopy is performed under local anaesthetic and patients are required to attend hospital clinics for the test. About one in 10 patients who are investigated for haematuria will be found to have bladder cancer. Frequently, patients are not referred for investigation of haematuria at the time of first presentation and there is a delay in diagnosis of the disease. The early detection of bladder cancer by means of a non-invasive tumour marker test would impact on the management of the disease. There is an unmet need for a simple, non-invasive, highly sensitive and specific method for detecting bladder cancer.

This study will determine the accuracy of UroMark a high-throughput multiplex PCR test to detect bladder cancer in DNA from urine. The study will address the unmet clinical need to improve detection of bladder cancer. The rationale for the trial is based on proof of concept studies which provide compelling evidence that a panel of methylation markers can be applied to detect bladder cancer with high sensitivity and specificity. It will be also be possible to collect and store fractions of urine for assessment of other DNA related biomarkers as well as non-DNA assays for example cellular proteins, soluble biomarkers in urine supernatant and RNA transcripts in sediment cells. In this study we will compare the UroMark assay with established assays including urinary cytology, FISH as well as developing assays such as MCM5. In this proposal excess urine will be stored for these studies.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 3700 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: A Prospective Observational Study to Determine the Negative Predictive Value of UroMark to Rule Out the Presence of Bladder Cancer in Patients With Haematuria.
Actual Study Start Date : March 30, 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Intervention Details:
  • Other: Group
    Other Name: Observational

Primary Outcome Measures :
  1. Negative predictive value (NPV) of the UroMark test. [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Negative predictive value (NPV) of control assay (FDA approved urinary marker (UroVision)). [ Time Frame: Baseline ]
  2. Negative predictive value (NPV) against imaging (ultrasound/CT) [ Time Frame: Baseline ]
  3. Negative predictive value (NPV) against combination of UroMark and imaging. [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
Urine will be collected for analysis using UroMark assay.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with visible and non-visible haematuria (blood in urine) will be enrolled. About 10% of cases with haematuria will be found to have bladder cancer. For the majority of cases (60.5%), no cause is found. Other causes include stone disease (3.6%), benign prostate conditions (20-30%), renal disease (9.8%) infection (13%) and renal/prostate cancer (1%). The DETECT I study will determine if the UroMark test can be used to rule out bladder cancer in cases referred for investigation of haematuria.

Inclusion Criteria:

  • Participants must be over 18 years of age.
  • Participants undergoing investigation for visible and non-visible haematuria.
  • Able to give informed written consent.

Exclusion Criteria:

  • Unwilling to have standard haematuria investigations.
  • Unable to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02676180

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United Kingdom
London, United Kingdom, NW1 2BU
James Cook University Hospital
Middlesbrough, United Kingdom
Sponsors and Collaborators
University College, London
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Principal Investigator: John Kelly, FRCS (urol) UCL

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University College, London Identifier: NCT02676180     History of Changes
Other Study ID Numbers: 15/0883
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases