Actively Recruiting
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Led by Fox Chase Cancer Center · Updated on 2025-10-31
92
Participants Needed
2
Research Sites
236 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
J
Janssen Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with high grade T1 urothelial carcinoma who have chosen cystectomy after counseling
- Patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ unresponsive to intravesical therapy who have elected cystectomy
- Patients with cT2-T3 muscle invasive urothelial carcinoma planned for cystectomy
- Patients who received prior intravesical therapy or multiple transurethral resections can participate
- Male or female patients aged 18 years or older at time of consent
- Able and willing to follow study procedures
- Patients must have a non-contrast phase CT scan of chest, abdomen, and pelvis before or during screening
- Patients starting neoadjuvant systemic therapy must enroll before beginning treatment
- Ability to understand and sign informed consent and privacy authorization
You will not qualify if you...
- Patients undergoing cystectomy without curative intent
- Patients who had previous definitive pelvic radiation for bladder cancer treatment
- Pregnant or nursing patients
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Trial Site Locations
Total: 2 locations
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
2
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
A
Alexander Kutikov, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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