Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

Study Overview
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Brief Summary
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To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective way to detect BCa, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and grade with a comparable accuracy, specificity and sensibility of the current gold standard histopathological analysis

Detailed Description
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Observational single center study on human biological samples to evaluate the possibility to discriminate between healthy and tumor tissue on urothelial bladder samples. Aim of the study is to provide a fast, reliable and label free aid/alternative to current histopathology

Official Title
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Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

Conditions
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Bladder Tumor

Intervention / Treatment
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* Diagnostic Test: Multimodal spectroscopic analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: willingness to participate, legal age, full capacity to sign informed consent eligibility for each surgical operation according to the best clinical practice and the urological guidelines Exclusion Criteria: concomitant use of Hexaminolevulinate (Hexvix®) concomitant ongoing UTIs, concomitant bladder stone presence, recent catheterization or persistent bladder catheterization at time of surgery, concomitant presence of other pelvic cancer (both prostate, urethral, uterine), previous chemotherapy or radiotherapy of the pelvis, patient refusal at informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic urologic patients<br>Patients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures. | Diagnostic Test: Multimodal spectroscopic analysis<br>* During time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa were taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic concordance | concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard | 30 minutes from resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grading concordance | concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard | 30 minutes from resection | 
| staging concordance | concordance in discriminating Ta vs T1 vs T2 tumors between multimodal fiberoptic spectroscopy and pathology, considered as gold standard | 30 minutes from resection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladdder Cancer, Urothelial tumor, Pathology, Spectroscopy, BCa