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Non-muscle-invasive Bladder CancerEVALUATIONNCT05864599

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

An observational study of Non-muscle-invasive Bladder Cancer, run by Pharmalink at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Independent validation of Uromonitor as a non-invasive biomarker of recurrence of Non Muscle Invasive Bladder Cancer Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Non-muscle-invasive Bladder Cancer
How many people
600 participants
Where
1 siteSpain
Study dates
16 Jun 2023to Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Presence of vesico-vaginal fistulae
  • Non informative cystoscope due to macroscopic haematuria or cloudy urine
  • Other conditions avoiding a clear tumour rule-out cystoscope

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Vithas 9 d'Octubre

    Valencia, 46015

Other trials in Spain

About this study

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

Read the 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)
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years after diagnosis

Secondary outcomes (2)

  1. Statistics in CIS, treated or not

    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

    Measured: 2 years after diagnosis

  2. Early diagnostics

    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)

    Measured: 4 years after diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start16 Jun 2023
  3. Primary completionMay 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05864599
Sponsor's protocol ID
PIEM-AEU-2023-0001
Acronym
EVALUATION
Status last verified
Apr 2024
First submitted
9 May 2023
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rubio-Briones J, Guerrero Ramos F, Mercade Sanchez A, Bezana Abadia I, Martin Rodriguez R, Alcaraz A, Miqueleiz Legaz M, Lozano F, Arrabal Martin M, Luis Cardo A, Gonzalo Rodriguez V, Cano Velasco J, Serrano Liesa M, Ferreiro Pareja C, Espilez Ortiz R, Gonzalez-Valcarcel de Torres I, Sanchez Zalabardo D, Guijarro A, Mengual L, Borque-Fernando A, Esteban Escano LM, Palou Redorta J, Witjes F, Martinez Pineiro L. Digital Uromonitor(R) outperforms quantitative polymerase chain reaction Uromonitor and cytology for non-muscle-invasive bladder cancer surveillance: results from the 'External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the Club Urologico Espanol de Tratamiento Oncologico Group' (EVALUATION-CUETO) study. BJU Int. 2026 Jul;138(1):75-84. doi: 10.1111/bju.70230. Epub 2026 Apr 6.

    PubMed 41941336

Questions about this trial

What is this clinical trial studying?

An observational study of Non-muscle-invasive Bladder Cancer, run by Pharmalink at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity, specificity, NPV and PPV of Uromonitor (time frame: 2 years after diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05864599, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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