Urologic Cancer, Urologic Neoplasms
Conditions
Keywords
Upper tract urothelial carcinoma, Urinary biomarker, Liquid biopsy, Epigenetics, Surveillance, Follow-up
Brief summary
Background: Upper tract urothelial carcinoma (UTUC) is a rare tumor associated with bladder cancer in up to 50% of cases. Its incidence is rising due to improved detection and bladder cancer survival. The diagnosis of UTUC is challenging because more than 35% of the standard biopsies can result inconclusive. The grading of UTUC cells, which delivers the most important data for the choice between a kidney-sparing surgery (KSS) and a radical treatment, is upgraded in 30% of radical nephroureterectomies. The follow-up of UTUC after KSS requires an invasive procedure as a diagnostic ureteroscopy for a minimum of 5 years, and urinary cytology has low diagnostic power. Objective: The aim of the study is to evaluate the accuracy (overall and stratified for grade) of a DNA methylation urine biomarker test (Bladder EpiCheckTM) in UTUC, and to compare it with current standard (urinary cytology). The secondary objective is to show its applicability in the specific clinical scenario of UTUC surveillance after kidney-sparing surgery and related cost-effectiveness. Design, Setting, and Participants: From February 2019 to February 2021, 80 consecutive patients candidates to ureteroscopy for suspicion of primary, recurrent or metachronous UTUC in one tertiary Referral Centers (Fundaciò Puigvert) giving written informed consent will be included in the study. Intervention: Bladder urine samples (\> 10 ml) will be collected for cytology and for the methylation test before cystoscopy. Prior to semirigid and flexible ureteroscopy, urine specimens from the upper urinary tract will be obtained via a ureteral catheter.
Interventions
DIAGNOSTIC_TESTUrine biomarker
Bladder urine samples (\> 10 ml) will be collected for cytology and for the methylation test before cystoscopy. Prior to semirigid and flexible ureteroscopy, urine specimens from the upper urinary tract will be obtained via a ureteral catheter.
Sponsors
Nucleix Ltd.
Fundacio Puigvert
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suspected for primary or recurrent upper tract urothelial cancer requiring ureteroscopy
Exclusion criteria
* Metastatic disease with patient unfit for ureteroscopy * Positive cystoscopy (concomitant presence of bladder cancer) * Macroscopic hematuria not self-limiting requiring upfront nephroureterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, specificity, positive predictive value and negative predictive value of the test | Through study completion, an average of 1 year | To test the accuracy of the urine biomarker |
| Comparison with urinary cytology | Through study completion, an average of 1 year | To evaluate and compare performance of urinary cytology and urine biormarker |
| Evaluation of biormarker performance in bladder and upper tract | Through study completion, an average of 1 year | To compare the accuracy of the test in situ (upper tract) and in the bladder |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High grade/low grade tumors diagnosis | Through study completion, an average of 1 year | Sub-analysis on biormaker accuracy for low and high grade tumours |
| Impact of the urine biormaker for UTUC diagnosis | Through study completion, an average of 1 year | A decision-making analysis will be performed in patients with UTUC suspicion, reporting the net benefit, the number of unnecessary ureteroscopies avoided |
Countries
Spain
Contacts
Primary ContactAndrea Gallioli, MD
Backup ContactAlberto Breda, MD
Outcome results
None listed