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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04702347
Other study ID # C2018/35
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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