A diagnostic test for early bladder cancer detection

A Novel Multiplex Immunoassay for the Early Detection of Bladder Cancer

This study is testing a new urine test to see if it can help find bladder cancer earlier in people who are at high risk for the disease.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Locations: 2 sites (Long Beach, California and 1 other locations)
• Trial ID: NCT05347342 on ClinicalTrials.gov

What this trial studies

This study aims to enhance non-invasive detection of bladder cancer by validating a multiplex ELISA assay that targets a diagnostic signature in urine samples from patients at high risk for developing bladder cancer. Given that environmental factors like tobacco smoke significantly increase bladder cancer risk, the study focuses on identifying the disease before it becomes clinically apparent. Currently, many patients present with advanced stages of bladder cancer, which drastically reduces survival rates. By detecting bladder cancer at an earlier stage, the study hopes to improve patient outcomes and survival rates.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 and older with a significant history of tobacco exposure and no current malignancies.

Not a fit: Patients with a history of bladder cancer or those who have experienced hematuria in the past two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this diagnostic could lead to earlier detection of bladder cancer, significantly improving survival rates for patients.

How similar studies have performed: Other studies have explored early detection methods for bladder cancer, but this specific approach using a multiplex ELISA assay is relatively novel.

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)

Where this trial is running

Long Beach, California and 1 other locations

• Long Beach VA Healthcare System — Long Beach, California, United States (Recruiting)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Hideki Furuya — Cedars-Sinai Medical Center
• Study coordinator: Charles J Rosser

Conditions Bladder Cancer