Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

Completed

• Conditions: Bladder Tumor
• Interventions: Diagnostic Test: Multimodal spectroscopic analysis

• Registration Number: NCT04310813
• Lead Sponsor: Careggi Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2019-12-01
• Status Verified: 2020-03
• Study Completion: 2020-03-01
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-13
• Last Update Submitted: 2020-03-16
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic urologic patients	Multimodal spectroscopic analysis	Patients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures.

Primary Outcome Measures

Name	Time	Method
diagnostic concordance	30 minutes from resection	concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard

Secondary Outcome Measures

Name	Time	Method
staging concordance	30 minutes from resection	concordance in discriminating Ta vs T1 vs T2 tumors between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
grading concordance	30 minutes from resection	concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard