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

Sponsor

Fundacio Puigvert (Other)

Overall Status

Recruiting

CT.gov ID

NCT04702347

Collaborator

Nucleix Ltd. (Industry)

Enrollment

Location

24.9

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urologic Cancer Urologic Neoplasms	Diagnostic Test: Urine biomarker

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Anticipated Primary Completion Date :

Feb 28, 2021

Anticipated Study Completion Date :

Feb 28, 2021

Outcome Measures

Primary Outcome Measures

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

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