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Bladder CancerDETECT IINCT02781428

To Detect the Sensitivity of the UroMark Assay

An observational study of Bladder Cancer, run by University College, London at 19 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
How many people
1,643 participants
Where
19 sitesUnited Kingdom
Study dates
26 Sep 2016to 19 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Unwilling to undergo TURBT
  • Unable to give informed consent.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United Kingdom19 sites

  • Tameside General Hospital

    Ashton-under-Lyne

  • East Lancashire Hospitals NHS Trust

    Blackburn

  • Royal Bolton Hospital

    Bolton

  • The Pennine Acute Hospitals NHS Trust

    Bury

  • University Hospital Coventry

    Coventry

  • Medway Maritime Hospital

    Gillingham

  • University College London Hospital

    London, W1G 8PH

  • Royal Free London NHS Foundation Trust

    London

  • Macclesfield Hospital

    Macclesfield

  • Norfolk & Norwich University Hospital

    Norwich

  • King's Mill Hospital

    Nottingham

  • East Surrey Hospital

    Redhill

  • Northern Lincolnshire & Goole NHS Foundation Trust

    Scunthorpe

  • Western Sussex Hospitals NHS Foundation Trust

    Shoreham-by-Sea

  • Royal Shrewsbury Hospital

    Shrewsbury

  • Stepping Hill Hospital

    Stockport

  • University Hospital of North Tees

    Stockton-on-Tees

  • Royal Albert Edward Infirmary

    Wigan

  • New Cross Hospital

    Wolverhampton

Other trials in United Kingdom

About this study

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

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.

Read the 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
Conditions
Bladder Cancer
Medical subject headings
Urinary Bladder Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4

    Measured: 2 years

Secondary outcomes (2)

  1. The ability of the UroMark assay to detect the recurrence in NMIBC in patients undergoing cystoscopic surveillance for bladder cancer

    Measured: 2 years

  2. A comparison between UroMark and other control assays including molecular tests

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2016 (estimated)
  2. Study start26 Sep 2016
  3. Primary completion19 Dec 2018
  4. Study completion19 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
1,643 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02781428
Sponsor's protocol ID
16/0226
Acronym
DETECT II
Status last verified
Dec 2023
First submitted
11 May 2016
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • Tan WS, Teo CH, Chan D, Ang KM, Heinrich M, Feber A, Sarpong R, Williams N, Brew-Graves C, Ng CJ, Kelly J; DETECT II trial collaborators. Exploring patients' experience and perception of being diagnosed with bladder cancer: a mixed-methods approach. BJU Int. 2020 May;125(5):669-678. doi: 10.1111/bju.15008. Epub 2020 Feb 12.

    PubMed 31975539

  • Tan WS, Teo CH, Chan D, Heinrich M, Feber A, Sarpong R, Allan J, Williams N, Brew-Graves C, Ng CJ, Kelly JD; DETECT II trial collaborators. Mixed-methods approach to exploring patients' perspectives on the acceptability of a urinary biomarker test in replacing cystoscopy for bladder cancer surveillance. BJU Int. 2019 Sep;124(3):408-417. doi: 10.1111/bju.14690. Epub 2019 Mar 4.

    PubMed 30694612

  • Tan WS, Feber A, Dong L, Sarpong R, Rezaee S, Rodney S, Khetrapal P, de Winter P, Ocampo F, Jalil R, Williams NR, Brew-Graves C, Kelly JD. DETECT I & DETECT II: a study protocol for a prospective multicentre observational study to validate the UroMark assay for the detection of bladder cancer from urinary cells. BMC Cancer. 2017 Nov 15;17(1):767. doi: 10.1186/s12885-017-3758-7.

    PubMed 29141603

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer, run by University College, London at 19 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4 (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02781428, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.

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