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

NCT06396533 | Recruiting DMC

• 1 other identifier: GU-222, 24-4001
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 2

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

Keywords

cystectomy

Outcome Measures

Primary Outcomes (2)

• Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence

  Determine the utility of a novel, proprietary combined blood and urinary genomic biomarker (ctDNA and cfDNA) assay in predicting the presence or absence of a muscle-invasive bladder cancer at cystectomy when no disease is identified on systematic endoscopic evaluation (SEE, aka seeT0).

  2 years

• Utility of a DNA test for muscle-invasive bladder cancer presence

  Negative predictive value (NPV) of a negative ctDNA and urine-based cfDNA assay to determine the presence or absence of muscle-invasive bladder cancer (pTmi0) on final cystectomy pathology in patients undergoing radical cystectomy with a pre-surgical seeT0 bladder.

  2 years

Secondary Outcomes (2)

• Accuracy of surgical specimen DNA test to predict muscle-invasive disease

  2 years

• Statistical accuracy evaluation of blood-based ctDNA assay for muscle-invasive bladder cancer presence

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria. Eligible patients will have bio specimen collected in accordance with the trial protocol.

You may qualify if:

• Properly counselled patients with high grade T1 disease who elect for cystectomy
• 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
• cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy
• 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).
• Male or female patients age \>=18 years at the time of consent.
• Able and willing to comply with study requirements.
• 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.
• Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy.
• Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.

You may not qualify if:

• Patients who undergo cystectomy with non-curative intent will be excluded.
• Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
• Patients who are pregnant or nursing.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (2)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood and urinary genomic biomarker (ctDNA and cfDNA)

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Alexander Kutikov, M.D.

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Kutikov, M.D.

CONTACT

215-728-3096; alexander.kutikov@fccc.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: May 2, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): April 23, 2027
• Study Completion (Estimated): February 23, 2029
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (2)