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| Name | Class |
|---|---|
| Vitadx | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Experimental | Patient in whom newly diagnosed, or recurring / progressing bladder cancer is strongly suspected after initial fibroscopy |
|
| Control | Experimental | Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own | at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the 4 different tests | Sensibility Comparaison between :
| at inclusion |
| Specificity of the 4 different tests |
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INCLUSION CRITERIA
BOTH GROUPS
CASE GROUP
CONTROL GROUP
EXCLUSION CRITERIA BOTH GROUPS
CASE GROUP • Under 18y/o
CONTROL GROUP
• Under 18y/o or above 45 y/o
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| Name | Affiliation | Role |
|---|---|---|
| Eschwège Pascal, MD, PhD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D009369 | Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D059349 | Urine Specimen Collection |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. |
|
Specificity Comparaison between :
| at inclusion |
| Positive predictive value of the 4 different tests | Positive predictive value between :
| at inclusion |
| Negative predictive value of the 4 different tests | Negative predictive value between :
| at inclusion |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |