A Diagnostic for the Early Detection of Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT05347342
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria:<br><br>Participants must be:<br><br> 1. Age 50 years or older<br><br> 2. >20 pack year history of tobacco exposure<br><br> 3. Free of any malignancy except for the following: adequately treated basal cell or<br> squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II<br> cancer from which the patient is currently in complete remission, or any other<br> cancer from which the patient has been disease free for five years. Patients with<br> localized prostate cancer who are being followed by an active surveillance program<br> are also eligible.<br><br> 4. Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening<br> Clinic<br><br> 5. Willing and able to give written informed consent<br><br> 6. Willing to provide voided urine sample<br><br> 7. Be able and willing to complete semi-annual research clinic visits for 4 years<br><br>Exclusion Criteria:<br><br>Participants must not have:<br><br> 1. History of hematuria (microscopic or gross) within 2 years of signing consent.<br><br> 2. Previous history of bladder cancer<br><br> 3. A known active urinary tract infection or urinary retention<br><br> 4. An active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0<br> mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise<br> repeat.<br><br> 5. An ureteral stents, nephrostomy tubes or bowel interposition<br><br> 6. A recent genitourinary instrumentation (within 7 days prior to collection of voided<br> urine sample)
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the ability to recruit and retain an appropriate high-risk group of subjects into a 4-year longitudinal study monitoring them for the development of bladder cancer.;2. To report the sensitivity and specificity of the multiplex immunoassay ability to detect bladder cancer in patients with high risk of developing bladder cancer: >50 years and >40 pack year history of tobacco exposure.;3. To develop a prediction risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.
- Secondary Outcome Measures
Name Time Method