NCT06396533 Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
| NCT ID | NCT06396533 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fox Chase Cancer Center |
| Condition | Urothelial Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2027-04-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 92 participants in total. It began in 2024-08-13 with a primary completion date of 2027-04-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Properly counselled patients with high grade T1 disease who elect for cystectomy 2. 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 3. cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy 4. 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). 5. Male or female patients age \>=18 years at the time of consent. 6. Able and willing to comply with study requirements. 7. 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. 8. Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy. 9. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document. Exclusion Criteria: 1. Patients who undergo cystectomy with non-curative intent will be excluded. 2. Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy. 3. Patients who are pregnant or nursing.
Contact & Investigator
Alexander Kutikov, M.D.
PRINCIPAL INVESTIGATOR
Fox Chase Cancer Center
Frequently Asked Questions
Who can join the NCT06396533 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06396533 currently recruiting?
Yes, NCT06396533 is actively recruiting participants. Contact the research team at alexander.kutikov@fccc.edu for enrollment information.
Where is the NCT06396533 trial being conducted?
This trial is being conducted at Omaha, United States, Philadelphia, United States.
Who is sponsoring the NCT06396533 clinical trial?
NCT06396533 is sponsored by Fox Chase Cancer Center. The principal investigator is Alexander Kutikov, M.D. at Fox Chase Cancer Center. The trial plans to enroll 92 participants.