NCT04718948|Unknown
Multimodal Spectroscopy to Detect Urothelial Cancer in Urine
"The Feasibility of a Multimodal Spectroscopy Analysis to Detect Urothelial Cancer in Urine"
Loading search results
"The Feasibility of a Multimodal Spectroscopy Analysis to Detect Urothelial Cancer in Urine"
Sponsor study identifier
observational
500
1 country
1
Study Start
January 28, 2021
Actual (reported)Primary Completion
December 20, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To facilitate the follow-up of urothelial tumors and also make them more tolerable and less invasive for patients, there is a minimally invasive and easy to perform examination which is urinary cytology on 3 samples. This test is extremely specific, over 90% chance of cancer if it is positive and is performed by expert cytopathologists, but it is burdened by a very low sensitivity, which is especially acute in the case of low grade tumors. This makes it an extremely useful test in case of positivity, but of little use if negative or doubtful, not being able to consider it reliable. To overcome this problem, our study aims to bring an approach based on a physical principle, that is spectroscopy, which is fast non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in samples of urine. In our experience, multimodal optical fiber spectroscopy has proved extremely valid in discriminating healthy urothelial tissue from tumor ex vivo, as well as providing important information on the degree of urothelial neoplasia, with accuracy rates higher than 80%, for which developed the idea of a technique based on multimodal spectroscopy. If our method proves valid, it could improve the follow up and management of patients with urothelial cancer, being able to support normal cytology and provide further support to the cytopathologist, as well as simplify the diagnosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 18, 2021
Actual (reported)January 22, 2021
Actual (reported)January 28, 2021
Actual (reported)December 20, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Urine Multimodal Spectroscopy Reliability
Evaluate whether multimodal spectroscopy can discriminate between healthy controls and patients with urothelial neoplasia on urine, with an accuracy at least comparable to urinary cytology on 3 samples
Enrollment
Urine Multimodal Spectroscopy Grading
Enrollment
Urine Multimodal Spectroscopy Site Discrimination
Enrollment
Patients will undergo urinary cytology, multimodal spectroscopy in urine and urologic surgical intervention The group of cases will consist of patients who meet the inclusion and exclusion criteria in the operative note for: * Transurethral Resection of Bladder Neoplasia (TURBT) * Radical Cystectomy for Bladder Neoplasia * Diagnostic ureterorenoscopy and / or laser treatment of ureteral and / or renal pelvis neoplasia * Segmental ureterectomy with or without ureteral reimplantation * Nephroureterectomy with or without bladder cuff excission
Patients will undergo urinary cytology, multimodal spectroscopy in urine and urologic surgical intervention The control group will consist of patients who meet the inclusion and exclusion criteria in the operative note for: * Transurethral Resection of Prostate (TURP) * Other endoscopic treatments of Benign Prostatic Hyperplasia (BPH) * Open interventions of prostatic adenomectomy * Endoscopic lithotripsy interventions of bladder stones or cystotomy with removal of bladder stones * Rigid and / or flexible ureterorenoscopy for the treatment of kidney and / or ureteral stones * Placement of ureteral catheter for ureteral and / or renal stones * Bladder Neck Incision (TUIP) * Endoscopic urethrotomy
Approach based on a physical principle, mainly spectroscopy, which is rapid non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in urine samples. It will be administered through a appositely designed device
Patients who meet the inclusion and exclusion criteria will be enrolled at Urology ward admission. Informed consent will be collected. Patients therapeutic routine will be unaffected. In the morning before surgery, the patient will collect urine sample. The patient will then continue the previously established diagnostic therapeutic process. The sample will be brought to the spectroscopic and cytological analysis. Samples will not be stored. According to the sample size calculation based on the asymptotic normal distribution theory, a total of 240 cases and 240 controls will be required if the study is to have 90% power. A series of 5000 simulations generating binary test data with a true positive frequency and a true negative frequency of 80% showed that these sample sizes produce 89% power. Increasing the sample size to 250 cases and 250 controls increases the potency to 90%. Therefore, approximately 250 cases and 250 controls will be enrolled in this phase 2 validation study.
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.
Mauro Gacci, MD
Careggi University Hospital
Enrico Baria, PhD
European Laboratory for Non-Linear Spectroscopy
Riccardo Cicchi, PhD
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Francesco Saverio Pavone, Prof
University of Florence
First Submitted
January 18, 2021
First Posted
January 22, 2021
Study Start
January 28, 2021
Actual (reported)Primary Completion
December 20, 2023
Estimated (date passed)Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy
An expert cytopathologist will analyze urine samples to detect urinary tract cancer cells. It is the current golden standard to detect urothelial cancer in urine
It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Sergio Serni, Prof
University of Florence
Gabriella Nesi, Prof
University of Florence
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 25, 2024
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
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: