Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
⁃ 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:
• 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
Locations
United States
California
Om Research LLC
RECRUITING
San Diego
Maryland
Chesapeake Urology Research Associates
RECRUITING
Towson
Contact Information
Primary
Limor Klein, PhD
limor.k@nucleix.com
+972-8-9161616
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 1000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Nucleix Ltd.