A phase II validation of in vivo Raman spectroscopy for bladder cancer diagnosis

Phase 2

Completed

• Conditions: bladder cancer; urothelial cell carcinoma; 10038364

• Registration Number: NL-OMON35830
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 285

Inclusion Criteria

Subjects (at least 18 years old and mentally competent) that present with bladder cancer symptoms at the outpatient clinic and are scheduled for transurethral resection of tumor or biopsy (TURTB) are candidates for recrution

Exclusion Criteria

Subjects scheduled for TURBT that present with macroscopic hematuria at the time of procedure are excluded from the study as the excess of blood in urine complicates the cystoscopic guidance to sites and affects the Raman spectra.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To differentiate between benign and malignant tumor in the bladder using in<br /><br>vivo Raman spectra for bladder cancer diagnosis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine grade and stage using in vivo Raman spectra for bladder cancer<br /><br>diagnosis</p><br>