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

NCT04702347 | Unknown

• 1 other identifier: C2018/35
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Urologic Cancer; Urologic Neoplasms

Keywords

Upper tract urothelial carcinoma; Urinary biomarker; Liquid biopsy; Epigenetics; Surveillance; Follow-up

Outcome Measures

Primary Outcomes (3)

• 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

• Comparison with urinary cytology

  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

  To compare the accuracy of the test in situ (upper tract) and in the bladder

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• High grade/low grade tumors diagnosis

  Through study completion, an average of 1 year

• Impact of the urine biormaker for UTUC diagnosis

  Through study completion, an average of 1 year

Interventions

Urine biomarker DIAGNOSTIC_TEST

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients suspected for primary or recurrent upper tract urothelial cancer requiring ureteroscopy

You may not qualify if:

• Metastatic disease with patient unfit for ureteroscopy
• Positive cystoscopy (concomitant presence of bladder cancer)
• Macroscopic hematuria not self-limiting requiring upfront nephroureterectomy

Sponsors & Collaborators

• Fundacio Puigvert: lead
• Nucleix Ltd.: collaborator

Study Sites (1)

Fundacio Puigvert

Barcelona, 08025, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine from upper urinary tract and bladder (at least 10 ml each)

MeSH Terms

Conditions

Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Central Study Contacts

Andrea Gallioli, MD

CONTACT

+34619588266; andrea.gallioli@gmail.com

Alberto Breda, MD

CONTACT

+34618018179; albbred@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Uro-Oncology Unit and Director of the Kidney Transplantation Division

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: February 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

ES (1)