A Diagnostic for the Early Detection of Bladder Cancer

Launched by CEDARS-SINAI MEDICAL CENTER · Apr 20, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to detect bladder cancer early by testing a specific type of urine sample. The goal is to see how well this new test can identify people who are at high risk for developing bladder cancer, especially those who have a history of smoking. By using urine samples, researchers hope to create a non-invasive method that is easier and safer than other testing methods.

To participate in this trial, you need to be at least 50 years old, have a significant history of smoking (more than 20 years), and be free of most cancers, except for certain types that have been treated successfully. You'll also need to be willing to provide urine samples and attend regular clinic visits for up to four years. If you qualify and decide to join, you will help researchers better understand bladder cancer detection, which could lead to improved outcomes for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants must be:
• • 1. Age 50 years or older
• • 2. \>20 pack year history of tobacco exposure
• • 3. 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.
• • 4. Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic
• • 5. Willing and able to give written informed consent
• • 6. Willing to provide voided urine sample
• • 7. Be able and willing to complete semi-annual research clinic visits for 4 years
• Exclusion Criteria:
• Participants must not have:
• • 1. History of hematuria (microscopic or gross) within 2 years of signing consent.
• • 2. Previous history of bladder cancer
• • 3. A known active urinary tract infection or urinary retention
• • 4. 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.
• • 5. An ureteral stents, nephrostomy tubes or bowel interposition
• • 6. A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)