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133 active trials for Urothelial Carcinoma

Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

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.

Start: December 2020
Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

To facilitate the follow-up of urothelial tumors and also make them more tolerable and less invasive for patients, there is a minimally invasive and easy to perform examination which is urinary cytology on 3 samples. This test is extremely specific, over 90% chance of cancer if it is positive and is performed by expert cytopathologists, but it is burdened by a very low sensitivity, which is especially acute in the case of low grade tumors. This makes it an extremely useful test in case of positivity, but of little use if negative or doubtful, not being able to consider it reliable. To overcome this problem, our study aims to bring an approach based on a physical principle, that is spectroscopy, which is fast non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in samples of urine. In our experience, multimodal optical fiber spectroscopy has proved extremely valid in discriminating healthy urothelial tissue from tumor ex vivo, as well as providing important information on the degree of urothelial neoplasia, with accuracy rates higher than 80%, for which developed the idea of a technique based on multimodal spectroscopy. If our method proves valid, it could improve the follow up and management of patients with urothelial cancer, being able to support normal cytology and provide further support to the cytopathologist, as well as simplify the diagnosis.

Start: January 2021