Bladder Cancer, Hematuria, Upper Tract Urothelial Cancer, Urothelial Carcinoma (UC)
Conditions
Keywords
Non-muscle invasive bladder cancer, Muscle invasive bladder cancer, Upper tract urothelial carcinoma, Urine tumor DNA
Brief summary
This is a prospective, multicenter observational study designed to collect urine and tumor biospecimens and associated clinical data from patients undergoing evaluation, treatment, or surveillance for urothelial carcinoma.
Detailed description
All study participants will provide a urine sample at baseline, study enrollment. Each participant will then be followed longitudinally for up to 5 years during which urine, tissue (if applicable), and clinical data will be collected from the standard of care clinical visits. Urine samples will be collected in Convergent Genomics' proprietary urine collection system.
Interventions
None listed
Sponsors
Convergent Genomics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
GROUP 1: Bladder Cancer and/or Upper Tract UCC * Male or female ≥ 18 years of age who are scheduled for transurethral resection of bladder tumor (TURBT) and/or biopsy of urinary tract or * Patients on surveillance who are negative for recurrence or tumor at the time of study enrollment but have had previous urothelial cell carcinoma (UCC) or * Patients with muscle invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC) scheduled for NAC and/or subsequent radical cystectomy (RC) * Able to provide consent prior to diagnostic TURBT, nephroureterectomy, or administration of NAC and/or RC * Able to provide at least 20cc urine. If patient cannot void sufficient volume of urine, urologist can pull urine from the bladder via catheter or cystoscope. Urine should not be collected immediately after resection * Participation in other bladder cancer studies is allowed. Experimental therapy must be documented in the case report forms GROUP 2: Hematuria Controls * Male or female ≥ 18 years of age presenting with gross or microscopic hematuria as defined by standard of care * No evidence of and/or history of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection * Able to provide consent * Able to provide at least 20cc urine * Participation in other studies is allowed. Experimental therapy must be documented in the case report forms
Exclusion criteria
GROUP 1: Bladder Cancer and/or Upper Tract UCC * Clinical, symptomatic urinary tract infection at time of initial urine collection * Unable to provide adequate urine sample GROUP 2: Hematuria Controls \- Evidence and/or History of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Free Survival (RFS) | From enrollment through completion of available clinical follow-up, up to 5 years. | RFS is defined as the time from the urine specimen collection to the first histopathologically confirmed recurrence of urothelial carcinoma |
| Diagnostic Detection Performance in Hematuria Triage | From enrollment through completion of diagnostic evaluation, up to 5 years. | Sensitivity, specificity, positive predictive value and negative predictive value of the investigational urine assay for the detection of urothelial cancer among subjects undergoing evaluation for hematuria, comparing subjects with histopathologically confirmed cancer to subjects without evidence of cancer at the time of diagnostic workup. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison to Alternative Urine Biomarkers | From enrollment up to 5 years. | Comparison of the investigational urine biomarker to alternative urine biomarker assays, including cytology and UroVysion FISH, for the detection of urothelial cancer recurrence. Comparison will include lead time, sensitivity, specificity, negative predictive value, and positive predictive value. |
| Lead Time for Detection of Cancer Recurrence | From enrollment up to 5 years. | A subject with diagnostic lead time will be defined as a subject with a negative cystoscopy and concurrent positive investigational urine biomarker with confirmed urothelial cancer recurrence on study. Lead time will be calculated as the time from the positive urine biomarker result to the date of histopathologic confirmation. |
Countries
Puerto Rico, United States
Outcome results
None listed