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

Urologic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702347
• Other study ID #: C2018/35
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: January 2021
• Source: Fundacio Puigvert
• Contact: Andrea Gallioli, MD
• Phone: +34619588266
• Email: andrea.gallioli[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urologic Cancer
• Urologic Neoplasms

Intervention

Diagnostic Test:
• Urine 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.

Locations

Country	Name	City	State
Spain	Fundacio Puigvert	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio Puigvert	Nucleix Ltd.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity, positive predictive value and negative predictive value of the test	To test the accuracy of the urine biomarker	Through study completion, an average of 1 year
Primary	Comparison with urinary cytology	To evaluate and compare performance of urinary cytology and urine biormarker	Through study completion, an average of 1 year
Primary	Evaluation of biormarker performance in bladder and upper tract	To compare the accuracy of the test in situ (upper tract) and in the bladder	Through study completion, an average of 1 year
Secondary	High grade/low grade tumors diagnosis	Sub-analysis on biormaker accuracy for low and high grade tumours	Through study completion, an average of 1 year
Secondary	Impact of the urine biormaker for UTUC diagnosis	A decision-making analysis will be performed in patients with UTUC suspicion, reporting the net benefit, the number of unnecessary ureteroscopies avoided	Through study completion, an average of 1 year