An observational study in Urologic Cancer and Urologic Neoplasms, sponsored by Fundacio Puigvert. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Fundacio Puigvert · Observational
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.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's planned enrollment of 80 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
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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.
Exclusion Criteria:
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.
Sensitivity, specificity, positive predictive value and negative predictive value of the test
To test the accuracy of the urine biomarker
Time frame: Through study completion, an average of 1 year
Comparison with urinary cytology
To evaluate and compare performance of urinary cytology and urine biormarker
Time frame: 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
Time frame: Through study completion, an average of 1 year
High grade/low grade tumors diagnosis
Sub-analysis on biormaker accuracy for low and high grade tumours
Time frame: Through study completion, an average of 1 year
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
Time frame: Through study completion, an average of 1 year
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Fundacio Puigvert