To Detect the Sensitivity of the UroMark Assay
DETECT II
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
1 other identifier
observational
1,643
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 24, 2016
CompletedStudy Start
First participant enrolled
September 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2018
CompletedDecember 4, 2023
December 1, 2023
2.2 years
May 11, 2016
December 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4
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
2 years
A comparison between UroMark and other control assays including molecular tests
2 years
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Unwilling to undergo TURBT
- Unable to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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, W1G 8PH, United Kingdom
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
Related Publications (3)
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.
PMID: 31975539DERIVEDTan 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.
PMID: 30694612DERIVEDTan 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.
PMID: 29141603DERIVED
Biospecimen
Urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2016
First Posted
May 24, 2016
Study Start
September 26, 2016
Primary Completion
December 19, 2018
Study Completion
December 19, 2018
Last Updated
December 4, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
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.