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

Sponsor
Institut de Cancérologie de Lorraine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05151341
Collaborator
Vitadx (Other)
190
1
2
29
6.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Urine collection (150ml)
  • Other: Blood sample (20 ml)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
190 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer
Actual Study Start Date :
Dec 13, 2021
Anticipated Primary Completion Date :
May 13, 2024
Anticipated Study Completion Date :
May 13, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Case

Patient in whom newly diagnosed, or recurring / progressing bladder cancer is strongly suspected after initial fibroscopy

Diagnostic Test: Urine collection (150ml)
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)

Other: Blood sample (20 ml)
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.

Experimental: Control

Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology

Diagnostic Test: Urine collection (150ml)
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)

Outcome Measures

Primary Outcome Measures

  1. Specificity [at inclusion]

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

Secondary Outcome Measures

  1. Sensitivity of the 4 different tests [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 [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 [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 [at inclusion]

    Negative predictive value between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France 54519

Sponsors and Collaborators

  • Institut de Cancérologie de Lorraine
  • Vitadx

Investigators

  • Principal Investigator: Eschwège Pascal, MD, PhD, Institut de Cancérologie de Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier:
NCT05151341
Other Study ID Numbers:
  • 2021-A01054-37
First Posted:
Dec 9, 2021
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut de Cancérologie de Lorraine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022