Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

NCT ID: NCT04770974

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2022-12-07

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.

Conditions

Urothelial Carcinoma; Bladder Cancer; Urothelial Neoplasm; Urothelial Carcinoma Bladder; Urothelial Carcinoma in Situ

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Urothelial Carcinoma

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

Biomarkers and proteomics

Intervention Type: OTHER

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

Interventions

Biomarkers and proteomics

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: collaborator

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

OTHER_GOV

Sponsor Role: collaborator

Careggi Hospital

OTHER

Sponsor Role: collaborator

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Simone Morselli

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio Serni, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Mauro Gacci, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Careggi

Locations

Careggi Hospital

Florence, Tuscany, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Simone Morselli, MD

Role: CONTACT

simone.morselli@unifi.it

3473050852

Silvia Benemei, MD

Role: CONTACT

silvia.benemei@unifi.it

Facility Contacts

Simone Morselli

Role: primary

simone.morselli@unifi.it

3473050852

References

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.

Reference Type: BACKGROUND

PMID: 31343832 (View on PubMed)

Related Links

https://www.amplitude-imaging.com/

Related Info

Other Identifiers

17852_bio

Identifier Type: -

Identifier Source: org_study_id