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

Sponsor

Pharmalink (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05864599

Collaborator

(none)

600

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Outcome Measures

Primary Outcome Measures

Sensitivity, specificity, NPV and PPV of Uromonitor [2 years after diagnosis]
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

Secondary Outcome Measures

Statistics in CIS, treated or not [2 years after diagnosis]
To evaluate the clinical sensitivity and specificity of Uromonitor in the detection of bladder cancer recurrence in patients previously diagnosed (over the last 3 months to 3 years) of NMIBC with carcinoma in situ (CIS) associated and treated with BCG
Early diagnostics [4 years after diagnosis]
To check if Uromonitor can provide some early diagnostics of NIMBC by following for two years a group of false positive patients of both previous groups (Uromonitor Positive / Cystoscopy Negative)

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pharmalink

Investigators

Principal Investigator: José Rubio-Briones, MD PhD, Clinica Dr. Rubio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pharmalink

ClinicalTrials.gov Identifier:

NCT05864599

Other Study ID Numbers:

PIEM-AEU-2023-0001

First Posted:

May 18, 2023

Last Update Posted:

May 18, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Non-Muscle Invasive Bladder Neoplasms

Study Results

No Results Posted as of May 18, 2023