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.
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
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.
The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4
Measured: 2 years
Secondary outcomes (2)
The ability of the UroMark assay to detect the recurrence in NMIBC in patients undergoing cystoscopic surveillance for bladder cancer
Measured: 2 years
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.
- First posted24 May 2016 (estimated)
- Study start26 Sep 2016
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 31975539Tan 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 30694612Tan 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02781428
- Acronym / sponsor ID
- DETECT II / 16/0226
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,643 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling to undergo TURBT
- Unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4
Time frame: 2 years
2 secondary outcomes
The ability of the UroMark assay to detect the recurrence in NMIBC in patients undergoing cystoscopic surveillance for bladder cancer
Time frame: 2 years
A comparison between UroMark and other control assays including molecular tests
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 31975539Tan 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.
- Derived from this study: PubMed 30694612Tan 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.
- Derived from this study: PubMed 29141603Tan 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
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.