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

January 7, 2021 updated by: Alberto Breda, Fundacio Puigvert

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, positive predictive value and negative predictive value of the test
Time Frame: Through study completion, an average of 1 year
To test the accuracy of the urine biomarker
Through study completion, an average of 1 year
Comparison with urinary cytology
Time Frame: Through study completion, an average of 1 year
To evaluate and compare performance of urinary cytology and urine biormarker
Through study completion, an average of 1 year
Evaluation of biormarker performance in bladder and upper tract
Time Frame: Through study completion, an average of 1 year
To compare the accuracy of the test in situ (upper tract) and in the bladder
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High grade/low grade tumors diagnosis
Time Frame: Through study completion, an average of 1 year
Sub-analysis on biormaker accuracy for low and high grade tumours
Through study completion, an average of 1 year
Impact of the urine biormaker for UTUC diagnosis
Time Frame: 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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio Puigvert

Collaborators

Nucleix Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

February 28, 2021

Study Completion (Anticipated)

February 28, 2021

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2018/35

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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