Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder EpiCheck | Diagnostic Test | Methylation biomarker urine test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
Not provided
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Limor Klein, PhD | Contact | +972-8-9161616 | limor.k@nucleix.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Om Research LLC | Recruiting | San Diego | California | 92103 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Voided urine samples
| Chesapeake Urology Research Associates | Recruiting | Towson | Maryland | 21204 | United States |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |