Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Contact Information
Primary
Alexander Kutikov, M.D.
alexander.kutikov@fccc.edu
215-728-3096
Time Frame
Start Date:2024-08-13
Estimated Completion Date:2029-02-23
Participants
Target number of participants:92
Treatments
Non- neoadjuvant chemotherapy patients
Archival (FFPE) specimen of prior diagnostic TUR will be obtained.~For patients receiving neoadjuvant chemotherapy: Blood will be collected at pre-treatment/baseline, mid-treatment(C3D1), day of cystectomy, and then only serum/plasma 4-6 weeks (±2 weeks) post-cystectomy, and 6 months (±1 month) post-cystectomy.~For patients not receiving neoadjuvant chemotherapy: Freshly voided mid-stream urine will be collected on the day of cystectomy.
Neoadjuvant Chemotherapy (NAC) Patients
Archival (FFPE) specimen of prior diagnostic TUR will be obtained.~For patients not receiving neoadjuvant chemotherapy: Serum/plasma will be collected on the day of cystectomy, and only serum/plasma 4-6 weeks (±2 weeks) post-cystectomy, and 6 months (±1 month) post-cystectomy.~For patients receiving neoadjuvant chemotherapy: Freshly voided mid-stream urine will be collected from each subject at pre-treatment, mid-treatment (C3D1), and the day of cystectomy.~Stool samples will be collected in OMNIgene GUT kits. Patients who are not undergoing NAC, will be provided one kit for stool collection prior to cystectomy at baseline. All stool samples will be sent to Case Western Microbiome Core for analysis.