Checking for Bladder Cancer Before Planned Bladder Removal Surgery
Studies tests that look for leftover bladder tumor in adults planned for cystectomy.
Plain-language title generated from the registry record
Registry title: Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Key facts
- Where
- Omaha and Philadelphia, United StatesSee the 2 sites
Where in United States
- University of Nebraska Medical CenterOmaha, United StatesTaking people
- Fox Chase Cancer CenterPhiladelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fox Chase Cancer Center
- Trial code
- NCT06396533
- Record updated
- 2 November 2026
- Original description
This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy.Read full original descriptionShow less
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy.
Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.
Inclusion: Properly counselled patients with high grade T1 disease who elect for cystectomy; Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy; cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy; Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected); Male or female patients age >=18 years at the time of consent; Able and willing to comply with study requirements; Patients must have a non-contrast phase component for CT scans of chest/abdomen/pelvis either pre-existing (prior to accrual) or obtained during the screening process; Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy; Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.
Exclusion: Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy; Patients who undergo cystectomy with non-curative intent will be excluded; Patients who are pregnant or nursing.