NCT05151341Completed
Study of Combined VisioCyt Test and FGFR3 Mutations on a Urinary Sample to Diagnose Bladder Tumors
Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer
Source: ClinicalTrials.gov · Last updated 24 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 190 (actual)
- First submitted
- 1 Dec 2021
- Start date
- 13 Dec 2021
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Diseases
- Bladder cancer
- NCT number
- NCT05151341
What you commit to
- Study type: Interventional
- Participants enrolled: 190
- From 13 Dec 2021 to the primary completion date, 12 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient that received renal transplantation (BK virus)
- Patient that received pelvis radiotherapy (related to prostatic cancer, gynecologic cancer or pelvic digestive cancer)
Other illness
- Non-treated current urinary infection
- Patient with another pelvic cancer
- Bladder cancer outside of urothelial carcinoma
Other
- Associated carcinoma of the high urinary apparatus
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.