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Completed

NCT Number: NCT02647112

Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.

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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–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tubingen University Medical Center, Tübingen, Germany

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma
  • Has all urothelial cell carcinoma tumor resected within the past 12 months
  • Has a plan for cystoscopic surveillance

Exclusion criteria

  • Planning to undergo radical cystectomy or chemotherapy-radiation for UCC

Treatment and study plan

Bladder EpiCheck

Other

Urine test for the monitoring of bladder cancer recurrence

Primary outcomes

  1. Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)

    Time frame: Day 1

    the proportion of positives that are correctly identified as such by the gold standard

  2. Specificity (the proportion of negatives that are correctly identified as such by the gold standard)

    Time frame: Day 1

    the proportion of negatives that are correctly identified as such by the gold standard

Sponsors and collaborators

Lead sponsor

Nucleix Ltd.

Industry

Registry information

Official study title

Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 6, 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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