Genetic Testing in Upper Tract Urothelial Carcinoma (UTUC): the Epicheck Study

• Conditions: Urologic Cancer; Urologic Neoplasms

• Registration Number: NCT04702347
• Lead Sponsor: Fundacio Puigvert

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Fundacio Puigvert; 🇪🇸 Barcelona, Spain