Genetic Testing in Upper Tract Urothelial Carcinoma (UTUC): the Epicheck Study
NCT ID: NCT04702347
Last Updated: 2021-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2019-02-01
2021-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Positive cystoscopy (concomitant presence of bladder cancer)
* Macroscopic hematuria not self-limiting requiring upfront nephroureterectomy
18 Years
ALL
No
Sponsors
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Nucleix Ltd.
INDUSTRY
Fundacio Puigvert
OTHER
Responsible Party
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Alberto Breda
Chief of the Uro-Oncology Unit and Director of the Kidney Transplantation Division
Locations
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Fundacio Puigvert
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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C2018/35
Identifier Type: -
Identifier Source: org_study_id
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