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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Fox Chase Cancer Center
Study ID
NCT06396533
Status
Recruiting
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Conditions

  • Muscle Invasive Bladder Urothelial Carcinoma
  • Non-Muscle Invasive Bladder Urothelial Carcinoma
  • Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Aug 13, 2024
Status verified
Oct 2025
Primary completion
Apr 23, 2027
Completion
Feb 23, 2029

Study Design

Enrollment
92 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Jared Schober, MD
Jared Schober, MD (PRINCIPAL_INVESTIGATOR)
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Alexander Kutikov, M.D.
[email protected]
215-728-3096

Find similar trials in Omaha, NE

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Nebraska Medical Center· Omaha, NEFox Chase Cancer Center· Philadelphia, PA

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