Improving tumor detection before bladder cancer surgery
Official title: Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
Run by Fox Chase Cancer Center · NCT06396533 · Data updated 2026-11-12
This study is testing a new combination of tests to see if they can accurately find leftover tumors in bladder cancer patients before they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | Fox Chase Cancer Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Omaha, Nebraska and 1 other locations) |
| Status | Recruiting |
| Started | August 13, 2024 |
| Main results expected | April 23, 2027 |
| Study ends | February 23, 2029 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT06396533 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with high-grade T1 or muscle invasive urothelial carcinoma who are planning to undergo cystectomy.
✕Probably not a fit
Patients with low-grade tumors or those who are not candidates for cystectomy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the effectiveness of a combined diagnostic panel that includes systematic endoscopic evaluation, a blood-based ctDNA assay, and a urine-based cfDNA assay to predict the presence of residual tumors in patients scheduled for cystectomy due to bladder cancer. The primary goal is to determine the negative predictive value of these tests in patients with no muscle invasive tumors prior to surgery. Eligible patients include those with high-grade non-muscle invasive or muscle invasive urothelial carcinoma who are considering cystectomy. Samples will be collected before and after the procedure to correlate diagnostic findings with final pathology results.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate pre-surgical assessments and better treatment outcomes for bladder cancer patients.
How similar studies have gone: Other studies have shown promise in using ctDNA and cfDNA assays for tumor detection, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
University of Nebraska Medical Center
Omaha, Nebraska, United States Recruiting -
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Alexander Kutikov, M.D. — Fox Chase Cancer Center
- Study coordinator: Alexander Kutikov, M.D.
- Email: alexander.kutikov@fccc.edu
- Phone: 215-728-3096
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy
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Urothelial Carcinoma Biospecimen Collection and Data Study
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ctDNA-based monitoring in muscle-invasive bladder cancer
This study tests whether a blood-based ctDNA test can flag residual or returning disease in adults with muscle-invasive bladder cancer undergoing standard treatments.
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BMS-986504 combined with standard treatments for certain metastatic MTAP‑deleted solid tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.