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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04770974
Other study ID # 17852_bio
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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