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

NCT ID: NCT05864599

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2024-06-30

Brief Summary

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

Detailed 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)

Conditions

Non-muscle-invasive Bladder Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Main Outcome:

• Age >22.
• Patients with a history of non-muscle invasive bladder cancer (any risk group, any intravesical adjuvant treatment received) over the last 3 months to 2 years, initial or recurrent, undergoing regular cystoscopic surveillance. The criteria for cystoscope FU 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 of CIS over the last 3 months to 3 years, and previously treated with BCG undergoing regular 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 a negative cystoscopy to be followed by two years as previously described depending on initial NMIBC risk group. The rest of the patients will also be followed 2 years to detect later recurrences/progression figures.

Exclusion Criteria

• Patients who are unable to provide the minimum amount of urine needed to perform one test.

• Patients planning to undergo radical cystectomy or chemotherapy, radiation for UC
• Patients at risk for non-definitive information derived from the cystoscope due to 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmalink

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Rubio-Briones, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital 9 d'Octubre

Locations

Hospital Vithas 9 d'Octubre

Valencia, , Spain

Countries

Spain

Other Identifiers

PIEM-AEU-2023-0001

Identifier Type: -

Identifier Source: org_study_id