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Bladder CancerNCT05344937

Validation Study of Uromonitor in High Risk Microhematuria Patients

An observational study of Bladder Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Men over 40 years of age, and women over 50, smokers or former smokers with a smoking rate greater than 10 packs/year and the presence of microhematuria >25 red blood cells per field in the microscopic analysis are at high risk of bladder cancer, so cystoscopy and uroTAC is advised in the AUA Guidelines. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Bladder Cancer
How many people
343 participants
Where
1 siteSpain
Study dates
2 May 2022to 1 May 2024
How long will I take part?
1 Month
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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Men and women seen for being at risk of lung cancer are included, and who present microhematuria above 25 red blood cells per field, so they are also at high risk for bladder cancer.

Who may be able to join

  • Men over 40 years of age or Women over 50 years of age.
  • Smokers or former smokers
  • Smoking rate >10 packs/year
  • Microhematuria with >25 red blood cells per hpf.

Who cannot join

  • Patients who refuse to undergo cystoscopy.
  • Patients who refuse or cannot perform imaging tests of the upper section due to allergy or chronic kidney disease.
  • History of macroscopic hematuria.
  • History of microscopic hematuria already known and studied.
  • Known cause of microhematuria: e.g. urinary infection, bladder lithiasis
  • Patients who refuse to participate in the study.

Trial locations and contacts

1 site in 1 country.

Felipe Villacampa contact

948255400

fvauba@unav.es

Spain1 site

  • Clinica Universidad de Navarra

    Madrid, 28027

    Felipe Villacampa, MD, 34913531920 ext. 6421, madridcunurologi@unav.es

Other trials in Spain

About this study

Official title: Estudio de validación de Uromonitor en el diagnóstico Precoz de cáncer Vesical en Pacientes de Alto Riesgo Con Microhematuria

Men over 40 years of age, and women over 50, smokers or former smokers with a smoking rate greater than 10 packs/year and the presence of microhematuria >25 red blood cells per field in the microscopic analysis are at high risk of bladder cancer, so cystoscopy and uroTAC is advised in the AUA Guidelines.

The investigators hypothesize if cystoscopy can be omitted in case of having a negative biomarker test and a normal uro-CT.

Main objective: To determine sensitivity, specificity, positive and negative predictive value of "Uromonitor" (molecular DNA based urine marker) in the included population, in relation to the presence of urothelial cancer in the bladder, comparing it with cystoscopy.

Read the detailed description
  1. Title: Validation study of Uromonitor in the early diagnosis of bladder cancer in high-risk patients with microhematuria. Version: 2.0. March 6, 2022. Main author: Felipe Villacampa Aubá. Department of Urology, University Clinic of Navarra (CUN).
  2. Justification and context. Patients with microhematuria and smokers have a high risk of having bladder cancer (5-10%), so a cystoscopy and Urotac should be performed. Cystoscopy is an uncomfortable test, which is rejected by many patients. The aim is to assess whether a urine molecular marker, already validated in other situations, is capable of substituting cystoscopy, improving the study of these patients and avoiding uncomfortable and invasive diagnostic tests for the patient.
  3. Hypotheses and research objectives. Hypothesis: Men over 40 years of age, and women over 50, smokers or ex-smokers with a smoking rate greater than 10 packs/year and the presence of microhematuria >25 red blood cells per field in the microscopic analysis (high risk) can omit cystoscopy in case of having a negative biomarker test and a normal uro-CT. Main objective: To determine sensitivity, specificity, positive and negative predictive value of "Uromonitor" in the included population, in relation to the presence of urothelial cancer in the bladder, comparing it with cystoscopy.
  4. Study design. This is a prospective observational study, in which the results of the "Uromonitor" test in urine are compared with the results of cystoscopy, a standard test in the population studied, to be able to detect urothelial cancer in the bladder. Patients seen at the University Clinic of Navarra by the Neurology Department (Pamplona and Madrid) with microhaematuria of more than 25 red blood cells per field will be included, being referred to urology department to study the risk of bladder cancer. There is the possibility of expanding the study to a center in Portugal with the same inclusion and exclusion criteria and the same protocol. This management is being carried out and will be confirmed throughout the study.
  5. Population. Population studied for opportunistic screening in lung cancer, which, if presenting a urine sediment with more than 25 red cells hps, is considered to be at high risk for bladder cancer according to the guidelines of the American Urological Association (AUA) of 2020.
  6. Variables.
  • Age
  • Sex
  • Date of birth
  • Smoking status (active smoker, ex-smoker)
  • Smoking rate
  • Red blood cells by field in microscopic analysis of urine
  • CT results
  • Urine cytology results
  • Cystoscopy results
  • Uromonitor results
  • Date of bladder TUR (if carried out)
  • Date of nephroureterectomy (if carried out)
  • Result of pathological anatomy (in case of biopsy or surgery)
  • Final diagnosis.
  1. Data sources. For the clinical variables, the usual medical records will be used. For the results of the uromonitor, the results sent by the manufacturer will be used.
  2. Study size. Assuming a prevalence of 7%, an expected sensitivity and specificity of 90%, and considering a confidence of 95% and a clinically acceptable precision of 12%, a sample size required for the study of 343 patients is estimated.
  3. Data analysis. Quantitative clinical and demographic variables will be described by mean and standard deviation. Qualitative variables will be described by absolute and relative distribution frequencies. The sensitivity, specificity, positive predictive value and negative predictive value of the test under evaluation will be estimated, with their respective 95% confidence intervals. Statistical analyzes will be performed using Stata software (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP).
Conditions
Bladder Cancer
Medical subject headings
Urinary Bladder Neoplasms

What is being measured

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

  1. Accuracy of Uromonitor in diagnosis of bladder cancer in high risk micro hematuria

    Specificity, sensibility, negative and positive predictive value of Uromonitor in high risk microhematuria patients

    Measured: 18 months

Secondary outcomes (1)

  1. acuracy of Uromonitor in diagnosis of high grade bladder tumours in this population

    Sensibility of uromonitor in detecting high grade bladder tumours

    Measured: 18 months

Timeline

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

  1. First posted25 Apr 2022
  2. Study start2 May 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion1 May 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
Case only
Time perspective
Prospective
Enrolment
343 participants (estimated)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT05344937
Sponsor's protocol ID
UROSCAVCUN
Status last verified
Apr 2022
First submitted
19 Apr 2022
Last updated
2 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Barocas DA, Boorjian SA, Alvarez RD, Downs TM, Gross CP, Hamilton BD, Kobashi KC, Lipman RR, Lotan Y, Ng CK, Nielsen ME, Peterson AC, Raman JD, Smith-Bindman R, Souter LH. Microhematuria: AUA/SUFU Guideline. J Urol. 2020 Oct;204(4):778-786. doi: 10.1097/JU.0000000000001297. Epub 2020 Jul 23.

    PubMed 32698717

  • Laukhtina E, Shim SR, Mori K, D'Andrea D, Soria F, Rajwa P, Mostafaei H, Comperat E, Cimadamore A, Moschini M, Teoh JY, Enikeev D, Xylinas E, Lotan Y, Palou J, Gontero P, Babjuk M, Witjes JA, Kamat AM, Roupret M, Shariat SF, Pradere B; European Association of Urology-Young Academic Urologists (EAU-YAU): Urothelial Carcinoma Working Group. Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non-muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis. Eur Urol Oncol. 2021 Dec;4(6):927-942. doi: 10.1016/j.euo.2021.10.003. Epub 2021 Nov 6.

    PubMed 34753702

  • Sieverink CA, Batista RPM, Prazeres HJM, Vinagre J, Sampaio C, Leao RR, Maximo V, Witjes JA, Soares P. Clinical Validation of a Urine Test (Uromonitor-V2(R)) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients. Diagnostics (Basel). 2020 Sep 24;10(10):745. doi: 10.3390/diagnostics10100745.

    PubMed 32987933

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra 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 4 inclusion and 6 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 2 May 2022. 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?

Contact Felipe Villacampa (948255400, fvauba@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of Uromonitor in diagnosis of bladder cancer in high risk micro hematuria (time frame: 18 months). 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 NCT05344937, which also lists 3 linked publications.

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 2 May 2022.

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