Bladder Cancer
Conditions
Keywords
FGFR3, VisioCyt, Bladder Tumor, Cancer, FGFR3 Mutation, Diagnosis, Cytoloogy
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.
Interventions
DIAGNOSTIC_TESTUrine 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)
OTHERBlood 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.
Sponsors
Vitadx
Institut de Cancérologie de Lorraine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | at inclusion | Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the 4 different tests | at inclusion | Sensibility Comparaison between : 1. Visiocyt test + FGFR3 analysis 2. FGFR3 analysis on its own 3. Visiocyt test on its own 4. Standard cytology |
| Specificity of the 4 different tests | at inclusion | Specificity Comparaison between : 1. Visiocyt test + FGFR3 analysis 2. FGFR3 analysis on its own 3. Visiocyt test on its own 4. Standard cytology |
| Positive predictive value of the 4 different tests | at inclusion | Positive predictive value between : 1. Visiocyt test + FGFR3 analysis 2. FGFR3 analysis on its own 3. Visiocyt test on its own 4. Standard cytology |
| Negative predictive value of the 4 different tests | at inclusion | Negative predictive value between : 1. Visiocyt test + FGFR3 analysis 2. FGFR3 analysis on its own 3. Visiocyt test on its own 4. Standard cytology |
Countries
France
Outcome results
None listed