Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04770974
• Other study ID #: 17852_bio
• Status: Recruiting
• Start date: December 10, 2020
• Est. completion date: December 7, 2022

Study information

• Verified date: May 2022
• Source: University of Florence
• Contact: Simone Morselli, MD
• Phone: 3473050852
• Email: simone.morselli[@]unifi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urothelial Carcinoma
• Urothelial Carcinoma Bladder
• Urothelial Carcinoma in Situ
• Urothelial Neoplasm

Intervention

Other:
• Biomarkers and proteomics
Biomolecular, proteomic, metabolomic and spectroscopy characterization of urothelial bladder neoplasia, on a 3D culture model (organoid) obtained from bladder tumor tissue

Locations

Country	Name	City	State
Italy	Careggi Hospital	Florence	Tuscany

Sponsors (4)

Lead Sponsor	Collaborator
University of Florence	Careggi Hospital, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomic	Metabolomic characteristic of bladder cancer	Enrollment
Primary	Spectroscopy	Spectroscopical characteristic of bladder cancer	Enrollment
Secondary	Progression	Comparison between different progression pattern among bladder cancer	Seven years
Secondary	Response to treatments	Comparison between different treatment response pattern among bladder cancer	Seven years
Secondary	Survival	Comparison between different survival outcomes among bladder cancer	Seven years
Secondary	Transcriptomic	Transcriptomic characteristic of bladder cancer	Enrollment

External Links

•   Related Info