Imperial Bladder 1 - Fluorescence COnfocal Microscopy for raPid evaluation of detrusor muscle at primary transurethraL rsEctTion of bladdEr tumours (IB1-LaserCOMPLETE)
Not Applicable
- Conditions
- Bladder cancerCancer
- Registration Number
- ISRCTN16114765
- Lead Sponsor
- Imperial College Healthcare NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Patients undergoing initial or first transurethral resection of bladder tumour (TURBT) for suspected bladder cancer.
Exclusion Criteria
1. Radiological or clinical suspicion of muscle-invasive bladder cancer (cT2-T4)
2. Prior diagnosis of NMIBC or MIBC on prior resection
3. Patients who do not consent for ex vivo tissue research through Imperial College Healthcare Tissue Bank (ICHTB)
4. Patients enrolled in concurrent clinical trials requiring ex vivo tissue for research
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The feasibility of using digital fluorescence confocal microscopy to identify the presence/absence of detrusor muscle in primary transurethral resection of bladder tumour (TURBT) specimens measured by a pathologist who will determine the accuracy at one timepoint
- Secondary Outcome Measures
Name Time Method 1. Establish a standard operating procedure for scanning fresh bladder tissue from primary TURBTs using the Histolog FCM machine at one timepoint <br>2. Agreement of digital FCM with the pathology report for detrusor presence on a specimen at a patient level. Sensitivity, specificity, positive and negative predictive value of digital FCM for detection of detrusor muscle with traditional H&E histopathology as the reference standard, on a per-patient basis at one timepoint <br>2. Agreement between readers measured by: a) two individual histopathologists; and, by b) a histopathologist versus an operating urological surgeon (Cohen’s kappa coefficient) at one timepoint <br>