To Detect the Sensitivity of the UroMark Assay

Bladder Cancer Clinical Trial

— DETECT II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781428
• Other study ID #: 16/0226
• Status: Completed
• Start date: September 26, 2016
• Est. completion date: December 19, 2018

Study information

• Verified date: December 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1643
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
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	Royal Free London NHS Foundation Trust	London
United Kingdom	University College London Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4		2 years
Secondary	The ability of the UroMark assay to detect the recurrence in NMIBC in patients undergoing cystoscopic surveillance for bladder cancer		2 years
Secondary	A comparison between UroMark and other control assays including molecular tests		2 years