Actively Recruiting
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
Led by Fox Chase Cancer Center · Updated on 2025-10-31
92
Participants Needed
2
Research Sites
96 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
Researchers are investigating a combined diagnostic approach to better detect residual tumor presence in the bladder before planned cystectomy in bladder cancer patients. This study focuses on patients with various stages of urothelial carcinoma, including high grade T1, non-muscle invasive high grade Ta or carcinoma in situ unresponsive to treatment, and muscle invasive cT2-T3 disease. The goal is to evaluate how well tests like systematic endoscopic evaluation (SEE), blood-based circulating tumor DNA (ctDNA) assay, and urine-based cell-free DNA (cfDNA) assay predict muscle-invasive tumor presence. The study involves collecting tissue samples from prior transurethral resection of bladder tumor (TURBT), urine, and blood at baseline before cystectomy. During surgery, additional tissue biopsies and samples are taken. Patients are grouped based on whether they receive neoadjuvant chemotherapy or not, with different schedules for blood, urine, and stool sample collections. After cystectomy, diagnostic test results are compared with the final surgical pathology to assess accuracy. Follow-up blood samples are collected at 4-6 weeks and 6 months post-procedure, with optional samples at 12 and 24 months for ongoing surveillance and research. Participants will undergo various assessments including cystoscopy, biopsies, and sample collections before and after surgery. Researchers will analyze these samples to measure the accuracy of urine and blood biomarkers in detecting muscle-invasive bladder cancer. Safety and disease status will be monitored over two years with regular imaging and laboratory tests. The study requires participants to comply with study procedures and provide informed consent, with the total follow-up period extending to at least two years after surgery.
CONDITIONS
Brief 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 electing cystectomy
- Patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ unresponsive to intravesical therapy electing cystectomy
- Patients with cT2-T3 muscle invasive urothelial carcinoma planned for cystectomy
- Patients who have had prior intravesical therapy or multiple TURBTs
- Male or female patients aged 18 years or older at consent
- Able and willing to comply with study requirements
- Must have a non-contrast CT scan of chest/abdomen/pelvis pre-existing or obtained during screening
- Patients receiving neoadjuvant systemic therapy must enroll before starting therapy
- Ability to understand and sign informed consent and HIPAA authorization
You will not qualify if you...
- Patients undergoing cystectomy with non-curative intent
- Patients who had prior definitive pelvic radiation for bladder cancer treatment
- Patients who are pregnant or nursing
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline prior to cystectomy
Participants undergo pre-surgical tissue, urine, and blood sample collection to evaluate tumor presence before cystectomy.
1 baseline visit (in-person)
Duration - Day of cystectomy
Participants undergo radical cystectomy with tissue biopsies and additional blood and urine sample collection on the day of surgery.
1 visit (in-person, day of procedure)
Duration - Up to 2 years post-cystectomy
Participants provide blood samples for ctDNA analysis and surveillance at multiple time points after cystectomy. Optional long-term blood sample collections may occur at 12 and 24 months post-procedure.
Visits at 4-6 weeks, 6 months, with optional visits at 12 and 24 months post-procedure (in-person)
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.
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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