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Trial Title:
External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the CUETO Group
NCT ID:
NCT05864599
Condition:
Non-muscle-invasive Bladder Cancer
Conditions: Official terms:
Non-Muscle Invasive Bladder Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
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)
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
22 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Vithas 9 d'Octubre
Address:
City:
Valencia
Zip:
46015
Country:
Spain
Start date:
June 16, 2023
Completion date:
June 2024
Lead sponsor:
Agency:
Pharmalink
Agency class:
Industry
Source:
Pharmalink
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05864599
