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NCT04770974

Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

Status unknown Last updated 9 May 2022
What this trial tests

trial testing Biomarkers and proteomics in Urothelial Carcinoma in 200 participants. Status unknown.

Timeline
10 December 2020
Primary endpoint
7 December 2022
7 December 2022

Quick facts

Lead sponsorUniversity of Florence
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment200
Start date10 December 2020
Primary completion7 December 2022
Estimated completion7 December 2022
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Florence

Who can join

18 and older, any sex, with Urothelial Carcinoma or Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Preclinical and Clinical Applications of Metabolomics and Proteomics in Glioblastoma Research.
    Ahmed M, Semreen AM, El-Huneidi W, Bustanji Y, et al · · 2022 · cited 16× · PMID 36613792 · DOI 10.3390/ijms24010348

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Other recruiting trials for Urothelial Carcinoma

Currently open trials in the same condition.

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Data sources for this page

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