Who is eligible for clinical trial NCT05347342?

Participants must meet protocol criteria for Bladder Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05347342 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-01-31

A Diagnostic for the Early Detection of Bladder Cancer (NCT05347342)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Cedars-Sinai Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (7 items).

Location: Long Beach VA Healthcare System — Long Beach, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria: 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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Long Beach VA Healthcare System — Long Beach, California
Cedars-Sinai Medical Center — Los Angeles, California

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗