Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Recruiting now
Conditions studied: Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, Non-Muscle Invasive Bladder Urothelial Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06396533
- Run by
- Fox Chase Cancer Center
- People needed
- 92
- Starts
- 2024-08-13
- Expected to finish
- 2029-02-23
- Last updated by the study team
- 2025-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients who undergo cystectomy with non-curative intent will be excluded.
- Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
- Patients who are pregnant or nursing.
Where it is running
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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