Status:
RECRUITING
A Diagnostic for the Early Detection of Bladder Cancer
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Nonagen Bioscience Corporation
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Brief Summary
To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patie...
Detailed Description
Environmental exposures, specifically tobacco smoke, increases the risk of many cancers, including bladder cancer. To date, there are no diagnostics capable of detecting bladder cancer early, that is ...
Eligibility Criteria
Inclusion
- Participants must be:
- Age 50 years or older
- \>20 pack year history of tobacco exposure
- Free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
- Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic
- Willing and able to give written informed consent
- Willing to provide voided urine sample
- Be able and willing to complete semi-annual research clinic visits for 4 years
Exclusion
- Participants must not have:
- History of hematuria (microscopic or gross) within 2 years of signing consent.
- Previous history of bladder cancer
- A known active urinary tract infection or urinary retention
- An active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat.
- An ureteral stents, nephrostomy tubes or bowel interposition
- A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)
Key Trial Info
Start Date :
April 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05347342
Start Date
April 29 2022
End Date
December 30 2026
Last Update
August 15 2025
Active Locations (2)
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1
Long Beach VA Healthcare System
Long Beach, California, United States, 90712
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048