Recruiting

Observational Study

Sponsor:

Fox Chase Cancer Center

Code:

NCT06396533

Conditions

Urothelial Carcinoma

Muscle Invasive Bladder Urothelial Carcinoma

Non-Muscle Invasive Bladder Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Urothelial Carcinoma

Muscle Invasive Bladder Urothelial Carcinoma

Non-Muscle Invasive Bladder Urothelial Carcinoma

Study ID

NCT06396533

Start date

Aug 13, 2024

Status verified date

Oct, 2025

Completion date

Feb 23, 2029

Anticipated

Primary completion date

Apr 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

92 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence [ Time Frame: 2 years ]
  • Utility of a DNA test for muscle-invasive bladder cancer presence [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Principal Investigator:

Jared Schober, MD

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • cystectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2025-10-31.