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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

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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

  1. 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

ArmDescriptionAssigned 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.
  • Diagnostic Test: Bladder EpiCheck
    Methylation biomarker urine test
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.
  • Diagnostic Test: Bladder EpiCheck
    Methylation biomarker urine test
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.
  • Diagnostic Test: Bladder EpiCheck
    Methylation biomarker urine test

Recruiting Locations

Om Research LLC
San Diego, California 92103
Contact:
Gavriushina
858.429.7050
agavriushina@omclinicaltrials.com

Chesapeake Urology Research Associates
Towson, Maryland 21204
Contact:
Phelps
410-205-8590
stephanie.phelps@chesuro.com

More Details

Status
Recruiting
Sponsor
Nucleix Ltd.

Study Contact

Limor Klein, PhD
+972-8-9161616
limor.k@nucleix.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.