Brief Title
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
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.
Study Type
Observational
Primary Outcome
Metabolomic
Secondary Outcome
Progression
Condition
Urothelial Carcinoma
Intervention
Biomarkers and proteomics
Study Arms / Comparison Groups
Urothelial Carcinoma
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
200
Start Date
December 10, 2020
Completion Date
December 7, 2022
Primary Completion Date
December 7, 2022
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sergio Serni, Prof, 3473050852, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04770974
Organization ID
17852_bio
Responsible Party
Principal Investigator
Study Sponsor
University of Florence
Collaborators
University of Milano Bicocca
Study Sponsor
Sergio Serni, Prof, Principal Investigator, University of Florence
Verification Date
May 2022