Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-03-27
Brief Title:
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy INSITE
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
None
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?:
None