NCT03122964

Multi Institutional Study in Patient Presenting With Hematuria

Multi Institutional Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples From A Cohort Of Patients With Hematuria

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,148 (actual)
• Sponsor: MDx Health · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.

Detailed description

The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria. The secondary objective is to evaluate the predictive accuracy of a risk model including clinical factors such as age, gender, smoking history, and presence of gross versus microscopic hematuria compared to a model incorporating the same risk factors along with the methylation marker panel.

Conditions

• Bladder Cancer
• Hematuria

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AssureMDx	combined panel of methylation and mutation markers for the detection of bladder cancer

Timeline

• Start date: 2017-03-31
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2017-04-21
• Last updated: 2019-03-06

Locations

1 site across 1 country: United States