Validation Study of Uromonitor in High Risk Microhematuria Patients

NCT05344937 | Unknown DMC

• 1 other identifier: UROSCAVCUN
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (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

  18 months

Secondary Outcomes (1)

• acuracy of Uromonitor in diagnosis of high grade bladder tumours in this population

  18 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto: collaborator

Study Sites (1)

Clinica Universidad de Navarra

Madrid, 28027, Spain

Location

Related Publications (3)

• 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.

  PMID: 32698717 BACKGROUND

• 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.

  PMID: 34753702 BACKGROUND

• 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.

  PMID: 32987933 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine DNA

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Felipe Villacampa, MD

  Clinica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felipe Villacampa

CONTACT

948255400; fvauba@unav.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: May 2, 2022
• Primary Completion: December 31, 2023
• Study Completion: May 1, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

ES (1)