Multi Institutional Study in Patient Presenting With Hematuria

MDx Health1,148 enrolled

Overview

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 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.

Study Type

OBSERVATIONAL

Enrollment

1,148

Conditions

Bladder Cancer Hematuria

Interventions

AssureMDxDIAGNOSTIC_TEST

combined panel of methylation and mutation markers for the detection of bladder cancer

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is willing and able to give written informed consent 2. Subject presents with or has a history of gross hematuria or microhematuria within the last 3 months Exclusion Criteria: 1. Subject has an active urinary tract infection, current urinary retention, active stone disease (renal or bladder), current ureteral stents or nephrostomy tubes, prior bowel interposition, or recent genitourinary instrumentation (within 10 days) 2. Subject has a current or past history of genitourinary or urologic cancer within 5 years 3. Subject has an active (untreated) cancer of any type, except basal cell skin cancer within 5 years

Locations (1)

UT Southwestern

Dallas, Texas, United States

Outcomes

Primary Outcomes

Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria.

Early detection of bladder cancer in patients presenting with hematuria

Time frame: 1 year

Secondary Outcomes

Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer.

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

Time frame: 1 year

Data from ClinicalTrials.gov

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