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.|
|ClinicalTrials.gov Identifier: NCT02781428|
Recruitment Status : Active, not recruiting
First Posted : May 24, 2016
Last Update Posted : October 9, 2019
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|
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 Type :||Observational|
|Actual Enrollment :||1643 participants|
|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|
- The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4 [ Time Frame: 2 years ]
- 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 ]
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): NCT02781428
|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, 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|