NCT03193515

A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.

Conditions

• Bladder Cancer

Timeline

• Start date: 2016-12-30
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2017-06-20
• Last updated: 2026-02-04

Locations

4 sites across 2 countries: United States, Japan