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NCT07514143 · ClinicalTrials.gov registry record
Bladder EpiCheck Product Development Study
A clinical trial, sponsored by Nucleix.
- Recruiting
- Registry status
- 1,000
- Enrollment target
NCT07514143: Recruiting study, sponsored by Nucleix.
NCT07514143 is a clinical trial that is actively recruiting participants, run by Nucleix. The registered enrollment target is 1,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07514143 is actively recruiting participants, sponsored by Nucleix.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Bladder EpiCheck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2025-09-15 |
| Est. Completion | 2026-12 |
What NCT07514143 shows while recruiting
NCT07514143 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Bladder EpiCheck is the first listed.
NCT07514143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07514143 about?
NCT07514143 is a clinical study titled "Bladder EpiCheck Product Development Study". 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 uri...
What is the current status of trial NCT07514143?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2025-09-15. Estimated completion is 2026-12.
What interventions are being tested in trial NCT07514143?
The interventions under investigation include: Bladder EpiCheck (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07514143?
This trial is sponsored by Nucleix, which has 5 total clinical trials registered on ClinicalTrials.gov.
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