Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

May 6, 2022 updated by: Simone Morselli, University of Florence

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Recruiting
        • Careggi Hospital
        • Principal Investigator:
          • Mauro Gacci, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolomic
Time Frame: Enrollment
Metabolomic characteristic of bladder cancer
Enrollment
Spectroscopy
Time Frame: Enrollment
Spectroscopical characteristic of bladder cancer
Enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression
Time Frame: Seven years
Comparison between different progression pattern among bladder cancer
Seven years
Response to treatments
Time Frame: Seven years
Comparison between different treatment response pattern among bladder cancer
Seven years
Survival
Time Frame: Seven years
Comparison between different survival outcomes among bladder cancer
Seven years
Transcriptomic
Time Frame: Enrollment
Transcriptomic characteristic of bladder cancer
Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Collaborators

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

Investigators

  • Principal Investigator: Mauro Gacci, MD, AOU Careggi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2020

Primary Completion (ANTICIPATED)

December 7, 2022

Study Completion (ANTICIPATED)

December 7, 2022

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (ACTUAL)

February 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17852_bio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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