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

This study is currently recruiting participants.
Verified August 2016 by University College, London
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781428
First Posted: May 24, 2016
Last Update Posted: November 4, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University College, London
  Purpose

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
Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4 [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • 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
Urine samples

Estimated Enrollment: 400
Study Start Date: September 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Prof John Kelly, MBBCh BAO,MD (res),FRCS Urol 020 7679 6490 j.d.kelly@ucl.ac.uk
Contact: Chris Brew-Graves 02076799280 situ.detect2@ucl.ac.uk

Locations
United Kingdom
university College London Hospital Recruiting
London, United Kingdom, W1G 8PH
Contact: Wei Shen Tan, MBBCh         
Sponsors and Collaborators
University College, London
  More Information

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02781428     History of Changes
Other Study ID Numbers: 16/0226
First Submitted: May 11, 2016
First Posted: May 24, 2016
Last Update Posted: November 4, 2016
Last Verified: August 2016
Individual Participant Data (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.

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases