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

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urine collection (150ml)
Blood sample (20 ml)
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring FGFR3, VisioCyt, Bladder Tumor, Cancer, FGFR3 Mutation, Diagnosis, Cytoloogy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancérologie de LorraineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Case

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sensitivity of the 4 different tests
Sensibility Comparaison between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology
Specificity of the 4 different tests
Specificity Comparaison between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology
Positive predictive value of the 4 different tests
Positive predictive value between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology
Negative predictive value of the 4 different tests
Negative predictive value between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology

Full Information

First Posted
December 1, 2021
Last Updated
July 27, 2023
Sponsor
Institut de Cancérologie de Lorraine
Collaborators
Vitadx
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1. Study Identification

Unique Protocol Identification Number
NCT05151341
Brief Title
Study of Combined VisioCyt Test and FGFR3 Mutations on a Urinary Sample to Diagnose Bladder Tumors
Acronym
URODX-FGFR3
Official Title
Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine
Collaborators
Vitadx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
FGFR3, VisioCyt, Bladder Tumor, Cancer, FGFR3 Mutation, Diagnosis, Cytoloogy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case
Arm Type
Experimental
Arm Description
Patient in whom newly diagnosed, or recurring / progressing bladder cancer is strongly suspected after initial fibroscopy
Arm Title
Control
Arm Type
Experimental
Arm Description
Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology
Intervention Type
Diagnostic Test
Intervention Name(s)
Urine collection (150ml)
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Blood sample (20 ml)
Intervention Description
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 Outcome Measure Information:
Title
Specificity
Description
Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Sensitivity of the 4 different tests
Description
Sensibility Comparaison between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology
Time Frame
at inclusion
Title
Specificity of the 4 different tests
Description
Specificity Comparaison between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology
Time Frame
at inclusion
Title
Positive predictive value of the 4 different tests
Description
Positive predictive value between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology
Time Frame
at inclusion
Title
Negative predictive value of the 4 different tests
Description
Negative predictive value between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology
Time Frame
at inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MERLIN Jean-Louis, PU PH
Phone
03 83 65 60 62
Ext
0033
Email
jl.merlin@nancy.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
HERMAN Marie Aude
Phone
03 83 53 86 68
Ext
0033
Email
m.herman@nancy.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eschwège Pascal, MD, PhD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eschwège Pascal, MD, PhD
Phone
03 83 59 84 17
Email
p.eschwege@nancy.unicancer.fr

12. IPD Sharing Statement

Learn more about this trial

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

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