Clinical Trial: Multi Institutional Study in Patient Presenting With Hematuria

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 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.

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.


Sponsor: MDx Health

Current Primary Outcome: Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria. [ Time Frame: 1 year ]

Early detection of bladder cancer in patients presenting with hematuria


Original Primary Outcome: Same as current

Current Secondary Outcome: Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer. [ Time Frame: 1 year ]

Accurately predict clinical risk of bladder cancer through clinical factors and methylation markers


Original Secondary Outcome: Same as current

Information By: MDx Health

Dates:
Date Received: April 12, 2017
Date Started: March 31, 2017
Date Completion: May 31, 2018
Last Updated: April 20, 2017
Last Verified: April 2017