Clinical trial NCT04770974: Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic
Official title: Definition of Tumor Bio-markers and Physical-spectroscopic Differences Between Healthy Urothelial Tissue Healthy and Urothelial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urothelial Carcinoma
Bladder Cancer
Urothelial Neoplasm
Urothelial Carcinoma Bladder
Urothelial Carcinoma in Situ
Keywords: spectroscopy
bladder cancer
urothelial carcinoma
tumor biomarkers
metabolomic
proteomic
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
name: Careggi Hospital
First posted: 2021-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo a surgical intervention for bladder cancer will be enrolled

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.


Eligibility criteria: 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

Primary outcomes:
measure: Metabolomic
timeFrame: Enrollment
measure: Spectroscopy
timeFrame: Enrollment
Secondary outcomes:
measure: Progression
timeFrame: Seven years
measure: Response to treatments
timeFrame: Seven years
measure: Survival
timeFrame: Seven years
measure: Transcriptomic
timeFrame: Enrollment
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi Hospital
state: Tuscany
Study officials:
affiliation: University of Florence
name: Sergio Serni, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU Careggi
name: Mauro Gacci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baria E, Morselli S, Anand S, Fantechi R, Nesi G, Gacci M, Carini M, Serni S, Cicchi R, Pavone FS. Label-free grading and staging of urothelial carcinoma through multimodal fibre-probe spectroscopy. J Biophotonics. 2019 Nov;12(11):e201900087. doi: 10.1002/jbio.201900087. Epub 2019 Aug 13.