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

NCT05864599 | Active Not Recruiting

• 1 other identifier: PIEM-AEU-2023-0001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-muscle-invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity, NPV and PPV of Uromonitor

  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

  2 years after diagnosis

Secondary Outcomes (2)

• Statistics in CIS, treated or not

  2 years after diagnosis

• Early diagnostics

  4 years after diagnosis

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmalink: lead

Study Sites (1)

Hospital Vithas 9 d'Octubre

Valencia, 46015, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• José Rubio-Briones, MD PhD

  Hospital 9 d'Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: June 16, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

ES (1)