An observational study in Bladder Tumor, sponsored by Careggi Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Careggi Hospital · Observational
To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective way to detect BCa, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and grade with a comparable accuracy, specificity and sensibility of the current gold standard histopathological analysis
Observational single center study on human biological samples to evaluate the possibility to discriminate between healthy and tumor tissue on urothelial bladder samples. Aim of the study is to provide a fast, reliable and label free aid/alternative to current histopathology
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's enrollment of 114 is below the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Careggi Hospital is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are enrolled at hospitalization in our Urology Ward for surgical operation. Patients in surgical note for TURBT for bladder cancer or for Trans-Urethral Resection of Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) are prospectively enrolled.
Age, history of bladder cancer, smoke habit and anamnesis are recorded before surgery. During time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa are taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes.
Specimens are sent to standard histopathological analysis. MFOS data are then compared to current gold standard methodology in order to develop a classification algorithm based on the spectral information provided by each technique.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures.
Diagnostic Test: Multimodal spectroscopic analysis
During time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa were taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes
diagnostic concordance
concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
Time frame: 30 minutes from resection
grading concordance
concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
Time frame: 30 minutes from resection
staging concordance
concordance in discriminating Ta vs T1 vs T2 tumors between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
Time frame: 30 minutes from resection
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2016 to primary completion in Dec 2019, 37 months.
Of 167 non-industry observational studies under Urinary Bladder Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 30. This study's 37 months is below that.
Counting every sponsor, half of 202 studies reached it within 60 months; a quarter within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Careggi Hospital