Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

NCT ID: NCT04310813

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2020-03-01

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

Conditions

Bladder Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopic urologic patients

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

Multimodal spectroscopic analysis

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Careggi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Villa

MD, clinical researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Morselli, MD

Role: STUDY_CHAIR

University of Florence

Other Identifiers

CEAVC 10325/2016

Identifier Type: -

Identifier Source: org_study_id