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NCT02781428: DETECT II

To Detect the Sensitivity of the UroMark Assay

Completed Last updated 4 December 2023
What this trial tests

trial in Bladder Cancer in 1,643 participants. Completed in 19 December 2018.

Timeline
26 September 2016
Primary endpoint
19 December 2018
19 December 2018

Quick facts

Lead sponsorUniversity College, London
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,643
Start date26 September 2016
Primary completion19 December 2018
Estimated completion19 December 2018
Sites19 locations across United Kingdom

Conditions studied

Sponsor

University College, London

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current status of development of methylation biomarkers for in vitro diagnostic IVD applications.
    Taryma-Leśniak O, Sokolowska KE, Wojdacz TK. · · 2020 · cited 64× · PMID 32631437 · DOI 10.1186/s13148-020-00886-6
  2. Exploring patients' experience and perception of being diagnosed with bladder cancer: a mixed-methods approach.
    Tan WS, Teo CH, Chan D, Ang KM, et al · · 2020 · cited 21× · PMID 31975539 · DOI 10.1111/bju.15008
  3. Emerging Roles of Urine-Based Tumor DNA Analysis in Bladder Cancer Management.
    Chaudhuri AA, Pellini B, Pejovic N, Chauhan PS, et al · · 2020 · cited 16× · PMID 32923907 · DOI 10.1200/po.20.00060
  4. Mixed-methods approach to exploring patients' perspectives on the acceptability of a urinary biomarker test in replacing cystoscopy for bladder cancer surveillance.
    Tan WS, Teo CH, Chan D, Heinrich M, et al · · 2019 · cited 16× · PMID 30694612 · DOI 10.1111/bju.14690
  5. 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.
    Tan WS, Feber A, Dong L, Sarpong R, et al · · 2017 · cited 16× · PMID 29141603 · DOI 10.1186/s12885-017-3758-7
  6. Perception of urinary biomarker tests among patients referred with suspected urological malignancy.
    Bullock N, Mubarak M, Morris C, Clements C, et al · · 2023 · cited 3× · PMID 37334021 · DOI 10.1002/bco2.234

Verify or expand the search:

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

Other University College, London trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02781428.

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