A Diagnostic for the Early Detection of Bladder Cancer
Running, not enrolling
Conditions studied: Bladder Cancer
In brief
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 patients with a high risk of developing bladder cancer.
Key facts
- Study ID
- NCT05347342
- Run by
- Cedars-Sinai Medical Center
- People needed
- 173
- Starts
- 2022-04-29
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-02-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Long Beach VA Healthcare System — Long Beach, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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