Clinical trial · Observational
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
NCT06396533CI-TRIAL-00096922INSITErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle Invasive Bladder Urothelial Carcinoma | Muscle Invasive Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-Muscle Invasive Bladder Urothelial Carcinoma | Non-Muscle Invasive Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Non- neoadjuvant chemotherapy patients
- description
- 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.
- label
- Neoadjuvant Chemotherapy (NAC) Patients
- description
- 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 outcomes (2)
- measure
- Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.