Clinical trial NCT04702347: Genetic Testing in Upper Tract Urothelial Carcinoma (UTUC): the Epicheck Study
Official title: Genetic Testing in Upper Tract Urothelial Carcinoma (UTUC): the Epicheck Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urologic Cancer
Urologic Neoplasms
Keywords: Upper tract urothelial carcinoma
Urinary biomarker
Liquid biopsy
Epigenetics
Surveillance
Follow-up
Lead sponsor: Fundacio Puigvert
Sponsor class: OTHER
Collaborators: name: Nucleix Ltd.
First posted: 2021-01-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients candidate to ureteroscopy for a radiological diagnosis or clinical suspicion for upper tract urothelial cancer in the period from February 1st 2019 to February 28th 2021 will be included in this study after giving informed written consent.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, specificity, positive predictive value and negative predictive value of the test
timeFrame: Through study completion, an average of 1 year
measure: Comparison with urinary cytology
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of biormarker performance in bladder and upper tract
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: High grade/low grade tumors diagnosis
timeFrame: Through study completion, an average of 1 year
measure: Impact of the urine biormaker for UTUC diagnosis
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundacio Puigvert
Study officials:
References: