Bladder EpiCheck Product Development Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bladder EpiCheck.
- Who it may be relevant to
- Registry conditions: Suspicion of Bladder Cancer, NMIBC Surveillance. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
Overview
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.
Interventions
- Diagnostic test Bladder EpiCheck
Methylation biomarker urine test
Primary outcome measures
- The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study. [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Age 22 or older
- Willing and able to sign the informed consent form
- Subject(s) that is planned to undergo ,within 60 days, one of the following procedures:
3.1 TURBT due to suspected or detected bladder tumor, or 3.2 Cystoscopy under general anesthesia due to suspected bladder tumor, or 3.3 Cystoscopy for NMIBC surveillance
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 2 centers
- Om Research LLC — San Diego
- Chesapeake Urology Research Associates — Towson
Identifiers
NCT: NCT07514143 · Nucleix