Clinical trial NCT05864599: External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the CUETO Group
Official title: External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the CUETO Group
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-muscle-invasive Bladder Cancer
Lead sponsor: Pharmalink
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 600
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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)

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

Primary outcomes:
measure: Sensitivity, specificity, NPV and PPV of Uromonitor
timeFrame: 2 years after diagnosis
Secondary outcomes:
measure: Statistics in CIS, treated or not
timeFrame: 2 years after diagnosis
measure: Early diagnostics
timeFrame: 4 years after diagnosis
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Vithas 9 d'Octubre
Study officials:
affiliation: Hospital 9 d'Octubre
name: José Rubio-Briones, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: