Bladder EpiCheck Product Development Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorNucleix Ltd.
About this trial
This is a prospective, observational study to support the development of the Bladder EpiCheck kit by collecting urine samples from subjects suspected to have a bladder tumor or under NMIBC surveillance.
This is a single visit study. Each subject will sign the informed consent and provide voided urine sample. Demography and, if performed, pathology information will be collected for each subject.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 22 or older
Willing and able to sign the informed consent form
Disqualifiers
Patients with known or history of muscle invasive bladder cancer (MIBC)
Treatment of prostate cancer or RCC in the past 2 years
Patients previously enrolled into this study within the prior 60 days
Trial population
Adult subjects who are planned to undergo within 60 days either TURBT, cystoscopy and anesthesia or cystoscopy without anesthesia. TURBT and cystoscopy under anesthesia should be due to detection or suspicion of bladder tumor, cystoscopy without anesthesia should be for NMIBC monitoring.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Bladder EpiCheck
Diagnostic testMethylation biomarker urine test
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: Subjects planned to undergo TURBT due to suspected or detected bladder tumor1 intervention
Group B: Subjects planned to undergo cystoscopy under general anesthesia due to suspected bladder tumor1 intervention
Group C: Subjects planned to undergo cystoscopy for NMIBC surveillance1 intervention
Trial outcomes
Primary outcomes
1
The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study.
The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study. For each product development protocol a pre-specified primary endpoint will be defined in a dedicated SAP. For example, validation of a new PCR platform will assess the rate of agreement between the approved PCR platform and the new new platform.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov