Bladder EpiCheck Product Development Study
Purpose
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.
Conditions
- Suspicion of Bladder Cancer
- NMIBC Surveillance
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 22 or older 2. Willing and able to sign the informed consent form 3. 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) 2. Treatment of prostate cancer or RCC in the past 2 years 3. Patients previously enrolled into this study within the prior 60 days
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Subjects planned to undergo TURBT due to suspected or detected bladder tumor | Adult subjects planned to undergo TURBT within 60 days due to suspected or detected bladder tumor (e.g., by cystoscopy, cytology, imaging) will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing. |
|
| Subjects planned to undergo cystoscopy under general anesthesia due to suspected bladder tumor | Adult subjects planned to undergo cystoscopy under general anesthesia ,within 60 days due to suspected bladder tumor will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing. |
|
| Subjects planned to undergo cystoscopy for NMIBC surveillance | Adult subjects planned to undergo cystoscopy for NMIBC surveillance ,within 60 days will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing. |
|
Recruiting Locations
Om Research LLC
San Diego, California 92103
San Diego, California 92103
Chesapeake Urology Research Associates
Towson, Maryland 21204
Towson, Maryland 21204
More Details
- Status
- Recruiting
- Sponsor
- Nucleix Ltd.