Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

NCT04310813 | Completed

• 1 other identifier: CEAVC 10325/2016
• Study Type: observational
• Target: 114
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bladder Tumor

Keywords

Bladdder Cancer; Urothelial tumor; Pathology; Spectroscopy; BCa

Outcome Measures

Primary Outcomes (1)

• diagnostic concordance

  concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard

  30 minutes from resection

Secondary Outcomes (2)

• grading concordance

  30 minutes from resection

• staging concordance

  30 minutes from resection

Study Arms (1)

Endoscopic urologic patients

Patients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures.

Diagnostic Test: Multimodal spectroscopic analysis

Interventions

Multimodal spectroscopic analysis DIAGNOSTIC_TEST

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

Endoscopic urologic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Careggi Hospital: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Simone Morselli, MD

  University of Florence

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, clinical researcher

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share