NCT05347342

A Diagnostic for the Early Detection of Bladder Cancer

A Novel Multiplex Immunoassay for the Early Detection of Bladder Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 173 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Environmental exposures, specifically tobacco smoke, increases the risk of many cancers, including bladder cancer. To date, there are no diagnostics capable of detecting bladder cancer early, that is prior to clinical presentation. Because of this severe limitation, nearly 30% of patients initially present with stage 2 and higher bladder cancer. Stage 2 bladder cancer has a 5-year survival of 50%, while stage 3/4 have a 5-year survival of \<20%. Ideally, bladder cancer would be preventable. Unfortunate, this has not come to fruition. If these stage 2-4 bladder cancer cases could be detected at Stage 1 (5-yr survival \>94%), then its possible to see an improvement in bladder cancer survival rates (21-23). in this study, a urine-based diagnostic that possesses the potential to accurately identify patients who harbor bladder cancer prior to clinical manifestation will be tested.

Conditions

• Bladder Cancer

Timeline

• Start date: 2022-04-29
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2022-04-26
• Last updated: 2026-02-03

Locations

2 sites across 1 country: United States