Urologic CancerNCT04702347
Genetic Testing in Upper Tract Urothelial Carcinoma (UTUC): the Epicheck Study
An observational study of Urologic Cancer and Urologic Neoplasms, run by Fundacio Puigvert at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Cancer, Urologic Neoplasms
- What is being tested?
- Urine biomarker
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients suspected for primary or recurrent upper tract urothelial cancer requiring ureteroscopy
Who cannot join
- Metastatic disease with patient unfit for ureteroscopy
- Positive cystoscopy (concomitant presence of bladder cancer)
- Macroscopic hematuria not self-limiting requiring upfront nephroureterectomy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundacio Puigvert
Barcelona, 08025
Andrea Gallioli, MD, +34619588266, andrea.gallioli@gmail.com
About this study
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.
Read more
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
- Being tested
- Urine biomarker
- Keywords
- Upper tract urothelial carcinoma, Urinary biomarker, Liquid biopsy, Epigenetics, Surveillance, Follow-up
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine biomarkerDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive predictive value and negative predictive value of the test
To test the accuracy of the urine biomarker
Measured: Through study completion, an average of 1 year
Comparison with urinary cytology
To evaluate and compare performance of urinary cytology and urine biormarker
Measured: 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
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
High grade/low grade tumors diagnosis
Sub-analysis on biormaker accuracy for low and high grade tumours
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Feb 2019
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Puigvert
- Sponsor type
- University, hospital or other
- Collaborators
- Nucleix Ltd.
- Responsible party
- Principal investigator, Alberto Breda, Fundacio Puigvert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702347
- Sponsor's protocol ID
- C2018/35
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Testing in Upper Tract Urothelial Carcinoma (UTUC): the Epicheck Study
- ClinicalTrials.gov ID
- NCT04702347
- Acronym / sponsor ID
- C2018/35
- Conditions
- Urologic Cancer, Urologic Neoplasms
- Keywords
- Upper tract urothelial carcinoma, Urinary biomarker, Liquid biopsy, Epigenetics, Surveillance, Follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fundacio PuigvertUniversity, hospital or other
- Collaborators
- Nucleix Ltd.
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients suspected for primary or recurrent upper tract urothelial cancer requiring ureteroscopy
Key exclusion criteria (3 listed)
- Metastatic disease with patient unfit for ureteroscopy
- Positive cystoscopy (concomitant presence of bladder cancer)
- Macroscopic hematuria not self-limiting requiring upfront nephroureterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine biomarkerBladder 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. | Diagnostic test | – |
Primary outcome
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
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
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
2 secondary outcomes
High grade/low grade tumors diagnosis
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Cancer and Urologic Neoplasms, run by Fundacio Puigvert at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Gallioli, MD (+34619588266, andrea.gallioli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, positive predictive value and negative predictive value of the test (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.