Clinical trial · Observational
Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
NCT07673016CI-TRIAL-00116195INSITErecruitingClinicalTrials.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 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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Hematuria | — | UNRESOLVED | — |
| Upper Tract Urothelial Cancer | — | UNRESOLVED | — |
| Urothelial Carcinoma (UC) | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC)
- label
- Hematuria Controls
Primary outcomes (2)
- measure
- Recurrence Free Survival (RFS)
- timeFrame
- From enrollment through completion of available clinical follow-up, up to 5 years.
- description
- RFS is defined as the time from the urine specimen collection to the first histopathologically confirmed recurrence of urothelial carcinoma
- measure
- Diagnostic Detection Performance in Hematuria Triage
- timeFrame
- From enrollment through completion of diagnostic evaluation, up to 5 years.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.