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To Detect the Sensitivity of the UroMark Assay (DETECT II)

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ClinicalTrials.gov Identifier: NCT02781428
Recruitment Status : Active, not recruiting
First Posted : May 24, 2016
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date May 11, 2016
First Posted Date May 24, 2016
Last Update Posted Date October 9, 2019
Actual Study Start Date September 26, 2016
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2016)
The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4 [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02781428 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 19, 2016)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title To Detect the Sensitivity of the UroMark Assay
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
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.

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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Urine samples
Sampling Method Non-Probability Sample
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.
Condition Bladder Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 16, 2019)
1643
Original Estimated Enrollment
 (submitted: May 19, 2016)
400
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02781428
Other Study ID Numbers 16/0226
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: 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.
Responsible Party University College, London
Study Sponsor University College, London
Collaborators Not Provided
Investigators Not Provided
PRS Account University College, London
Verification Date October 2019