- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04310813
Microscopic-spectroscopic Examination for Urothelial Tissue Characterization (MSUT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
Inclusion Criteria:
- willingness to participate,
- legal age,
- full capacity to sign informed consent
- eligibility for each surgical operation according to the best clinical practice and the urological guidelines
Exclusion Criteria:
- concomitant use of Hexaminolevulinate (Hexvix®)
- concomitant ongoing UTIs,
- concomitant bladder stone presence,
- recent catheterization or persistent bladder catheterization at time of surgery,
- concomitant presence of other pelvic cancer (both prostate, urethral, uterine),
- previous chemotherapy or radiotherapy of the pelvis,
- patient refusal at informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Endoscopic urologic patients
Patients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diagnostic concordance
Time Frame: 30 minutes from resection
|
concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
|
30 minutes from resection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
grading concordance
Time Frame: 30 minutes from resection
|
concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
|
30 minutes from resection
|
staging concordance
Time Frame: 30 minutes from resection
|
concordance in discriminating Ta vs T1 vs T2 tumors between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
|
30 minutes from resection
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Simone Morselli, MD, University of Florence
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEAVC 10325/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
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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