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Completed

NCT Number: NCT02700464

The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma

Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHN, Princess Margret Cancer center, Toronto, Ontario, Canada

Loading trial locations.

About this study

The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals.
  • Has had all urothelial cell carcinoma tumor resected within the past 12 months
  • Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
  • Able to provide legally effective informed consent
  • Able to produce 45mL of urine

Exclusion criteria

  • Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma

Treatment and study plan

Bladder EpiCheck Urine Test

Device

The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer

Cystoscopy and pathology

Procedure

Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy

Primary outcomes

  1. Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)

    Time frame: Day 1

  2. Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Nucleix Ltd.

Industry

Registry information

Official study title

The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2016
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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