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Completed

NCT Number: NCT05151341

Study of Combined VisioCyt Test and FGFR3 Mutations on a Urinary Sample to Diagnose Bladder Tumors

This study is a case-control, propsective and muticentric clinical trial, which aim to compare the specificity and sensibility of VisioCyt urinary cytological test combined with FGFR3 mutation detection test to VisioCyt urinary cyological test on its own to detect bladder cancer.

The case are patient in whom newly diagnosed, or recurring /progressing bladder cancer is strongly suspected after initial fibroscopy.

The control are patient attending or hospitalized for urolithiasis, urinary infections, urinary superior excretory stones or with non suspect urinary symptomatology.

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Key information

Conditions

Bladder Cancer Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

BOTH GROUPS

  • M/F
  • Patient agrees to follow study protocol and is able to follow study procedures
  • Patient signed, dated and understood consent form
  • Patient has a social security scheme

CASE GROUP

  • Patient is 18 or older
  • Patient for whom a bladder cancer recently diagnosed, or backsliding/progression is heavily suspected after the initial fibroscopy
  • Patient who hasn't started systemic/oral/radiotheurapeutic pelvic treatment for his/her tumor

CONTROL GROUP

  • Patient between 18 and 45 y/o
  • Patient not suspected of having any bladder cancer
  • Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology
  • Patient who hasn't been exposed to bladder carcinogens (tobacco, industrial carcinogen (ex: coal tar, tar/coal oils, coal pitch and burning coal soot), urinary bilharzia, chemotherapy exposition (cyclophosphamid)
  • Patient that had a negative cytopathological exploration of the excretory urinary route OR/AND iconography (pelvic echography, pelvic scanner) OR/AND endoscopy with prior urinary sample
  • Patient unscathed of any cancer that might interact with bladder cancer : uterine cancer, prostate cancer, rectal cancer, and metastasis from other cancer or non-urologic tumor invading the bladder

Exclusion criteria

BOTH GROUPS

  • Non-treated current urinary infection
  • Patient with another pelvic cancer
  • Bladder cancer outside of urothelial carcinoma
  • Associated carcinoma of the high urinary apparatus
  • Patient that received renal transplantation (BK virus)
  • Patient that received pelvis radiotherapy (related to prostatic cancer, gynecologic cancer or pelvic digestive cancer)
  • Patient having a JJ catheter
  • Refused to signed consent
  • Pregnant, susceptible to be, or breast-feeding women
  • Person Under guardianship
  • Impossibility to submit to medical monitoring because of geographic, social, or mental issues

CASE GROUP • Under 18y/o

CONTROL GROUP

  • Under 18y/o or above 45 y/o

Treatment and study plan

Urine collection (150ml)

Diagnostic Test

Urine collection will be tacken at inclusion. The sample will be thereafter separate into three to realise different analyzes (standard cytology, Visiocyt test, FGFR3 analysis)

Blood sample (20 ml)

Other

Blood sample will be tacken at inclusion, ONLY for "case" patients that agreed upon this. This sample will be addition to the collection for further research.

Primary outcomes

  1. Specificity

    Time frame: at inclusion

    Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own

Secondary outcomes

  1. Sensitivity of the 4 different tests

    Time frame: at inclusion

    Sensibility Comparaison between :

    • Visiocyt test + FGFR3 analysis
    • FGFR3 analysis on its own
    • Visiocyt test on its own
    • Standard cytology

  2. Specificity of the 4 different tests

    Time frame: at inclusion

    Specificity Comparaison between :

    • Visiocyt test + FGFR3 analysis
    • FGFR3 analysis on its own
    • Visiocyt test on its own
    • Standard cytology

  3. Positive predictive value of the 4 different tests

    Time frame: at inclusion

    Positive predictive value between :

    • Visiocyt test + FGFR3 analysis
    • FGFR3 analysis on its own
    • Visiocyt test on its own
    • Standard cytology

  4. Negative predictive value of the 4 different tests

    Time frame: at inclusion

    Negative predictive value between :

    • Visiocyt test + FGFR3 analysis
    • FGFR3 analysis on its own
    • Visiocyt test on its own
    • Standard cytology

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Collaborators

  • Vitadx

Registry information

Official study title

Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer

Acronym: URODX-FGFR3

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 9, 2021
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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