Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)

Active, not recruiting

• Conditions: Urothelial Carcinoma; Muscle Invasive Bladder Urothelial Carcinoma; Non-Muscle Invasive Bladder Urothelial Carcinoma

• Registration Number: NCT06396533
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Properly counselled patients with high grade T1 disease who elect for cystectomy<br><br> 2. Properly counselled patients with non-muscle invasive high grade Ta urothelial<br> carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have<br> elected cystectomy<br><br> 3. cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy<br><br> 4. Patient who have received prior intravesical therapy or multiple TURBTs can be<br> enrolled (data regarding number of previous TURBTs and type of intravesical therapy<br> will be collected).<br><br> 5. Male or female patients age >=18 years at the time of consent.<br><br> 6. Able and willing to comply with study requirements.<br><br> 7. Patients must have a non-contrast phase component for CT scans of<br> chest/abdomen/pelvis either pre-existing (prior to accrual) or obtained during the<br> screening process.<br><br> 8. Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must<br> be enrolled before starting systemic therapy.<br><br> 9. Ability to understand and willingness to sign a written informed consent and HIPAA<br> authorization document.<br><br>Exclusion Criteria:<br><br> 1. Patients who undergo cystectomy with non-curative intent will be excluded.<br><br> 2. Patients who have undergone previous definitive pelvic radiation for the purpose of<br> treating bladder malignancy.<br><br> 3. Patients who are pregnant or nursing.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence;Utility of a DNA test for muscle-invasive bladder cancer presence

Secondary Outcome Measures

Name	Time	Method
Accuracy of surgical specimen DNA test to predict muscle-invasive disease;Statistical accuracy evaluation of blood-based ctDNA assay for muscle-invasive bladder cancer presence