Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

NCT04770974 | Unknown

• 1 other identifier: 17852_bio
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Metabolomic

  Metabolomic characteristic of bladder cancer

  Enrollment

• Spectroscopy

  Spectroscopical characteristic of bladder cancer

  Enrollment

Secondary Outcomes (4)

• Progression

  Seven years

• Response to treatments

  Seven years

• Survival

  Seven years

• Transcriptomic

  Enrollment

Study Arms (1)

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

Other: Biomarkers and proteomics

Interventions

Biomarkers and proteomics OTHER

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

Urothelial Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will undergo a surgical intervention for bladder cancer will be enrolled

You may qualify if:

• Age\>18 years
• Bladder Cancer diagnosis
• Capability to express informed consent

You may not qualify if:

• Age under 18
• Pregnancy
• Lack of informed consent
• Inability to provide informed consent

Sponsors & Collaborators

• University of Florence: lead
• University of Milano Bicocca: collaborator
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator
• Careggi Hospital: collaborator

Study Sites (1)

Careggi Hospital

Florence, Tuscany, 50134, Italy

RECRUITING

Related 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.

  PMID: 31343832 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Sergio Serni, Prof

  University of Florence

  PRINCIPAL INVESTIGATOR

• Mauro Gacci, MD

  AOU Careggi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Morselli, MD

CONTACT

3473050852; simone.morselli@unifi.it

Silvia Benemei, MD

CONTACT

silvia.benemei@unifi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: December 10, 2020
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)