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To Detect the Sensitivity of the UroMark Assay (DETECT II)

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: NCT02781428
Recruitment Status : Active, not recruiting
First Posted : May 24, 2016
Last Update Posted : October 9, 2019
Information provided by (Responsible Party):
University College, London

Brief Summary:

This is a prospective multicentre observational study to assess the sensitivity of the UroMark assay to detect bladder cancer in participants with new or recurrent disease. The study will recruit patients with newly detected or recurrent bladder cancer. The reference standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade 1, 2 or 3 diseases with or without CIS, or CIS alone.

Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached and asked to consent for this study. Consenting participants will be provided with a urine sample collection kit and asked to provide a urine sample. Samples can be provided at home and posted to the receiving lab using the stamped addressed envelope. The urine sample must be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years.

The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study requiring provision of a urine sample, it will be possible for patients in DETECT II to be recruited to other trials.

Condition or disease
Bladder Cancer

Detailed Description:

This study is an observational study and participants will receive the standard of care according to local MDT guidelines for the treatment and surveillance of bladder cancer. As the study involves collection of a urine sample, subjects are permitted to be entered into other trials. The DETECT II study will recruit patients with newly diagnosed and recurrent bladder cancer. As this study is only observational and no intervention is trial related the patients will be given minimum 24 hours to consider this study and decide to take part as they will be approached in clinic at first instance. Due to the initial urine sample being required before any standard of care is received they will be consented within 24 hours of being informed of the study. Most newly diagnosed bladder cancers are detected in patients being investigated for haematuria and attending a haematuria clinic. Most recurrent bladder cancers are detected by cystoscopy at bladder cancer check cystoscopy clinics.

Patients with a visual diagnosis or new or recurrent bladder cancer will be eligible for the DETECT II study. The baseline UroMark urine collection will be collected once the visual diagnosis of bladder cancer is established. The UroMark sample must be provided before TURBT in all cases.

Patients will be approached following cystoscopy and asked to consent to study entry. The DETECT II study will involve obtaining a voided urine sample. Patients will be given a UroMark urine sample kit and asked to provide the urine sample at home and post the sample to the receiving lab using the stamped addressed envelope.

Patients will receive the standard tests and investigations for bladder cancer. The standard treatment for bladder cancer is summarised as:

  • TURBT following which it is recommended that patients with NMIBC receive a single instillation of chemotherapy unless contraindicated.
  • Intermediate risk NMIBC will be considered for a 6 week inductive course of intravesical chemotherapy after TURBT.
  • High risk NMIBC may require a second TURBT called re-resection TURBT, usually within 6 weeks of the first. The re--resection or second TURBT is performed for pathological stage pT1 tumours to exclude residual detrusor muscle invasion (stage pT2 at least). There are 2 treatment choices when the high risk status has been confirmed clinically:
  • A course of inductive followed by maintenance intravesical BCG
  • An operation to remove the bladder (a cystectomy).
  • Cystectomy or radiotherapy are the options for patients diagnosed with MIBC

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Study Type : Observational
Actual Enrollment : 1643 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Multicentre Observational Study Design to Determine the Sensitivity of the UroMark Assay, a Urine Test, to Detect New and Recurrent Low, Intermediate and High Grade Bladder Cancer
Actual Study Start Date : September 26, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The ability of the UroMark assay to detect the recurrence in NMIBC in patients undergoing cystoscopic surveillance for bladder cancer [ Time Frame: 2 years ]
  2. A comparison between UroMark and other control assays including molecular tests [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Urine samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
DETECT II will recruit patients attending haematuria clinics, check cystoscopy clinics or at pre-assessment clinic prior to TURBT. All patients who have a visual diagnosis of new or recurrent bladder cancer after flexible cystoscopy can be approached.

Inclusion Criteria:

  • Participants must be over 18 years of age.
  • Visual diagnosis or suspected diagnosis of bladder cancer following cystoscopy.
  • Able to give informed written consent to participate

Exclusion Criteria:

  • Unwilling to undergo TURBT
  • 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): NCT02781428

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United Kingdom
Tameside General Hospital
Ashton-under-Lyne, United Kingdom
East Lancashire Hospitals NHS Trust
Blackburn, United Kingdom
Royal Bolton Hospital
Bolton, United Kingdom
The Pennine Acute Hospitals NHS Trust
Bury, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
university College London Hospital
London, United Kingdom, W1G 8PH
Royal Free London NHS Foundation Trust
London, United Kingdom
Macclesfield Hospital
Macclesfield, United Kingdom
Norfolk & Norwich University Hospital
Norwich, United Kingdom
King's Mill Hospital
Nottingham, United Kingdom
East Surrey Hospital
Redhill, United Kingdom
Northern Lincolnshire & Goole NHS Foundation Trust
Scunthorpe, United Kingdom
Western Sussex Hospitals NHS Foundation Trust
Shoreham-by-Sea, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
Stepping Hill Hospital
Stockport, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, United Kingdom
Royal Albert Edward Infirmary
Wigan, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Sponsors and Collaborators
University College, London

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University College, London Identifier: NCT02781428     History of Changes
Other Study ID Numbers: 16/0226
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Papers will be prepared for publication in general and urological peer-reviewed journals. The findings will also be presented at national and international conferences. The results of the study will be disseminated regardless of the direction of effect. Authorship will be determined according to an agreed Publication Policy.
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases