Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-01-17 @ 4:51 AM
Study NCT ID:
NCT06396533
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSITE
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.
Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.
Detailed Description:
The principle outcome of this study is to determine the negative predictive value (NPV) of finding no muscle invasive (pT2) tumor in seeT0 patients with a negative result on the ctDNA assay prior to radical cystectomy.
Eligible candidates for radical cystectomy and INSITE trial:
* Patients with high grade T1 urothelial carcinoma who elect for "early" /upfront cystectomy
* Patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who have relapsed or are refractory / unresponsive to intravesical therapy and have elected to undergo cystectomy
* cT2-T3 muscle invasive urothelial carcinoma (irrespective of receipt of neo-adjuvant chemotherapy) Prior to cystectomy, tissue (transurethral resection of bladder tumor), urine and blood samples will be obtained at baseline for urine biopsy, ctDNA testing and future correlative studies.
After anesthetic induction for radical cystectomy, the patient will undergo rigid cystoscopy with targeted transurethral resection (TUR) of visible tumor or tumor bed, and two additional random bladder biopsies of normal-appearing bladder mucosa. Urine and blood samples will be obtained day of procedure for utilization for urine biopsy, ctDNA, and future correlative studies.
Following cystectomy, a diagnostic testing panel of pre-cystectomy cystoscopic and biopsy findings, ctDNA, and urine biopsy will be compared to final pathologic specimen.
Blood samples will be obtained 4-6 weeks (±2 weeks) post-procedure and 6 months (±1 month) post-procedure for analysis and ctDNA for post-procedure surveillance and other additional correlative studies. Additional blood sample collections at 12 months and 24 months post-procedure are optional.
Eligible candidates for radical cystectomy and INSITE trial:
* Patients with high grade T1 urothelial carcinoma who elect for "early" /upfront cystectomy
* Patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who have relapsed or are refractory / unresponsive to intravesical therapy and have elected to undergo cystectomy
* cT2-T3 muscle invasive urothelial carcinoma (irrespective of receipt of neo-adjuvant chemotherapy) Prior to cystectomy, tissue (transurethral resection of bladder tumor), urine and blood samples will be obtained at baseline for urine biopsy, ctDNA testing and future correlative studies.
After anesthetic induction for radical cystectomy, the patient will undergo rigid cystoscopy with targeted transurethral resection (TUR) of visible tumor or tumor bed, and two additional random bladder biopsies of normal-appearing bladder mucosa. Urine and blood samples will be obtained day of procedure for utilization for urine biopsy, ctDNA, and future correlative studies.
Following cystectomy, a diagnostic testing panel of pre-cystectomy cystoscopic and biopsy findings, ctDNA, and urine biopsy will be compared to final pathologic specimen.
Blood samples will be obtained 4-6 weeks (±2 weeks) post-procedure and 6 months (±1 month) post-procedure for analysis and ctDNA for post-procedure surveillance and other additional correlative studies. Additional blood sample collections at 12 months and 24 months post-procedure are optional.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: