Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

Study Overview
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Brief Summary
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Our multicenter observational study is a non-profit prospective study. The study was born from the Amplitude Project, which comprise the SOD of Minimally Invasive Robotic Urological Surgery and Renal Transplants of AOU Careggi with the University of Florence, as well as with the National Research Council (CNR) and the University of Milan Bicocca (UNIMIB) The study consists of a phase of enrollment of patients who will be admitted to the SOD of Mini Invasive Robotic Urological Surgery and Renal Transplantation of AOU Careggi. Enrollment in the study does not alter normal clinical practice and does not involve additional risks for patients. Patients will have to meet the inclusion and exclusion criteria of the study and will be enrolled sequentially, until the established sample size is reached. Patients undergoing surgery for the removal of bladder neoplasm, be it endoscopic or surgical with radical intent (cystectomy), will be taken a fragment of tumor bladder tissue, on which histopathological analysis will be performed. In patients undergoing radical cystectomy only, a fragment of healthy urothelial tissue, free from neoplasia, will also be removed. The samples will be performed in patients under general and / or spinal anesthesia in case of TURB, thus not causing pain or discomfort to the patient, or ex-vivo on the operative piece in case of radical cystectomy, without causing further damage or pain to the patient. From these samples, specially stored in solutions that keep their characteristics unaltered, a 3D culture model (organoid) will be obtained both from cells obtained from bladder cancer and from healthy tissue on which biomolecular, metabolomic and spectroscopic characterization studies will be tested and carried out. with a view to staging and grading bladder neoplasia.

Official Title
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Definition of Tumor Bio-markers and Physical-spectroscopic Differences Between Healthy Urothelial Tissue Healthy and Urothelial Cancer

Conditions
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Urothelial Carcinoma, Bladder Cancer, Urothelial Neoplasm, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ

Intervention / Treatment
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* Other: Biomarkers and proteomics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18 years Bladder Cancer diagnosis Capability to express informed consent Exclusion Criteria: Age under 18 Pregnancy Lack of informed consent Inability to provide 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 |
| --- | --- |
| Urothelial Carcinoma<br>Patients over the age of 18 known for urological interventions for the following pathologies will be considered for enrollment in the group of cases: - Bladder cancer The exclusion criteria will be: Age under 18 Pregnancy Lack of informed consent Inability to provide informed consent Patients included in the study, who meet the inclusion criteria, have an operative note for: Transurethral Resection of Bladder Neoplasia (TURBT) Radical Cystectomy for Bladder Neoplasia | Other: Biomarkers and proteomics<br>* Biomolecular, proteomic, metabolomic and spectroscopy characterization of urothelial bladder neoplasia, on a 3D culture model (organoid) obtained from bladder tumor tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomic | Metabolomic characteristic of bladder cancer | Enrollment | 
| Spectroscopy | Spectroscopical characteristic of bladder cancer | Enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression | Comparison between different progression pattern among bladder cancer | Seven years | 
| Response to treatments | Comparison between different treatment response pattern among bladder cancer | Seven years | 
| Survival | Comparison between different survival outcomes among bladder cancer | Seven years | 
| Transcriptomic | Transcriptomic characteristic of bladder cancer | Enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spectroscopy, bladder cancer, urothelial carcinoma, tumor biomarkers, metabolomic, proteomic