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Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04770974
Enrollment
200
Registered
2021-02-25
Start date
2020-12-10
Completion date
2022-12-07
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ, Urothelial Neoplasm

Keywords

spectroscopy, bladder cancer, urothelial carcinoma, tumor biomarkers, metabolomic, proteomic

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.

Interventions

OTHERBiomarkers and proteomics

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

Sponsors

University of Milano Bicocca
CollaboratorOTHER
Fondazione C.N.R./Regione Toscana G. Monasterio, Pisa, Italy
CollaboratorOTHER_GOV
Careggi Hospital
CollaboratorOTHER
University of Florence
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MetabolomicEnrollmentMetabolomic characteristic of bladder cancer
SpectroscopyEnrollmentSpectroscopical characteristic of bladder cancer

Secondary

MeasureTime frameDescription
ProgressionSeven yearsComparison between different progression pattern among bladder cancer
Response to treatmentsSeven yearsComparison between different treatment response pattern among bladder cancer
SurvivalSeven yearsComparison between different survival outcomes among bladder cancer
TranscriptomicEnrollmentTranscriptomic characteristic of bladder cancer

Countries

Italy

Contacts

Primary ContactSimone Morselli, MD
simone.morselli@unifi.it3473050852
Backup ContactSilvia Benemei, MD
silvia.benemei@unifi.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026