Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic
- Conditions
- Urothelial CarcinomaUrothelial Carcinoma BladderUrothelial NeoplasmBladder CancerUrothelial Carcinoma in Situ
- Interventions
- Other: Biomarkers and proteomics
- Registration Number
- NCT04770974
- Lead Sponsor
- University of Florence
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Age>18 years
- Bladder Cancer diagnosis
- Capability to express informed consent
- Age under 18
- Pregnancy
- Lack of informed consent
- Inability to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Urothelial Carcinoma Biomarkers and proteomics 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
- Primary Outcome Measures
Name Time Method Metabolomic Enrollment Metabolomic characteristic of bladder cancer
Spectroscopy Enrollment Spectroscopical characteristic of bladder cancer
- Secondary Outcome Measures
Name Time Method Transcriptomic Enrollment Transcriptomic characteristic of bladder cancer
Response to treatments Seven years Comparison between different treatment response pattern among bladder cancer
Survival Seven years Comparison between different survival outcomes among bladder cancer
Progression Seven years Comparison between different progression pattern among bladder cancer
Trial Locations
- Locations (1)
Careggi Hospital
🇮🇹Florence, Tuscany, Italy