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Definition of Tumor Bio-markers and Physical-spectroscopic Differences Between Healthy Urothelial Tissue Healthy and Urothelial Cancer
Sponsor study identifier
observational
200
1 country
1
Study Start
December 10, 2020
Actual (reported)Primary Completion
December 7, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 7, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 7, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2020
Actual (reported)February 22, 2021
Actual (reported)February 25, 2021
Actual (reported)December 7, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 7, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Metabolomic
Metabolomic characteristic of bladder cancer
Enrollment
Spectroscopy
Spectroscopical characteristic of bladder cancer
Enrollment
Progression
Seven years
Response to treatments
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
Biomolecular, proteomic, metabolomic and spectroscopy characterization of urothelial bladder neoplasia, on a 3D culture model (organoid) obtained from bladder tumor tissue
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who will undergo a surgical intervention for bladder cancer will be enrolled
Careggi Hospital
Florence, Tuscany, 50134, Italy
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.
Sergio Serni, Prof
University of Florence
Mauro Gacci, MD
AOU Careggi
First Submitted
February 22, 2021
First Posted
February 25, 2021
Study Start
December 10, 2020
Actual (reported)Primary Completion
December 7, 2022
Estimated (date passed)Seven years
Survival
Seven years
Transcriptomic
Enrollment
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 7, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 9, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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