NCT03193528

A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

Detailed description

Hematuria is the most common presentation of BCa with 22% of patients with gross hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

Conditions

• Bladder Cancer

Timeline

• Start date: 2016-12-30
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2017-06-20
• Last updated: 2026-02-04

Locations

6 sites across 2 countries: United States, Japan