External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the CUETO Group

Last updated: April 2, 2024
Sponsor: Pharmalink
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05864599
PIEM-AEU-2023-0001
  • Ages > 22
  • All Genders

Study Summary

Independent validation of Uromonitor as a non-invasive biomarker of recurrence of Non Muscle Invasive Bladder Cancer

Eligibility Criteria

Inclusion

Inclusion Criteria: Main Outcome:

  • Age >22.
  • Patients with a history of non-muscle invasive bladder cancer (any risk group, anyintravesical adjuvant treatment received) over the last 3 months to 2 years, initialor recurrent, undergoing regular cystoscopic surveillance. The criteria for cystoscopeFU schedule has been already described in Methods following EAU 2022 Guidelines´recommendations and related to initial NMIBC risk grouping.
  • Patient must be able to provide at least 10 ml of urine.
  • Additional 10 ml of urine needs to be collected for cytology.
  • Patients must be able to provide informed consent 2.- Subgroup analysis (secondary Objective 1):
  • Age >22
  • Patients with a history of primary non-muscle invasive bladder cancer with presence ofCIS over the last 3 months to 3 years, and previously treated with BCG undergoingregular cystoscopic surveillance.
  • Patient must be able to provide at least 10 ml of urine.
  • Additional 10 ml of urine needs to be collected for cytology.
  • Patients must be able to provide informed consent. 3.- Subgroup analysis (secondary Objective 2):
  • Age >22
  • Patients included in both previous groups, having a positive Uromonitor® test and anegative cystoscopy to be followed by two years as previously described depending oninitial NMIBC risk group. The rest of the patients will also be followed 2 years todetect later recurrences/progression figures.

Exclusion

Exclusion Criteria:

  • Patients who are unable to provide the minimum amount of urine needed to perform onetest.
  • Patients planning to undergo radical cystectomy or chemotherapy, radiation for UC
  • Patients at risk for non-definitive information derived from the cystoscope dueto different conditions:
  • Not possible to ascertain informative cystoscope due to intolerance to the procedure
  • Presence of bladder stone
  • Presence of entero-vesical fistulae
  • Presence of vesico-vaginal fistulae
  • Non informative cystoscope due to macroscopic haematuria or cloudy urine
  • Other conditions avoiding a clear tumour rule-out cystoscope

Study Design

Total Participants: 600
Study Start date:
June 16, 2023
Estimated Completion Date:
June 30, 2024

Study Description

This study is intended as an independent validation series for previous studies performed in several European centers with less statistical power. We expect to validate the results from a previous study, reaching the sensitivity and specificity data obtained at generation and first external validation papers. The overall goal of this study is to perform a bigger external multicenter validation study to evaluate the sensitivity, specificity, NPV and PPV of Uromonitor for the detection of bladder cancer recurrence in an independent series of patients.

The specific objectives of this study protocol are the following:

Main endpoint:

• To evaluate the clinical sensitivity, specificity, NPV and PPV of Uromonitor in the detection of bladder cancer recurrence in patients previously diagnosed (over the last 3 months to 2 years) of NMIBC, treated or not, by testing a total of 600 patients (EVALUATION-CUETO Study)

Connect with a study center

  • Hospital Vithas 9 d'Octubre

    Valencia, 46015
    Spain

    Site Not Available

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