Multi Institutional Study in Patient Presenting With Hematuria

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bladder Cancer, Hematuria

Intervention / Treatment
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* Diagnostic Test: AssureMDx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is willing and able to give written informed consent Subject presents with or has a history of gross hematuria or microhematuria within the last 3 months Exclusion Criteria: 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) Subject has a current or past history of genitourinary or urologic cancer within 5 years Subject has an active (untreated) cancer of any type, except basal cell skin cancer within 5 years

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with gross or microscopic hematuria<br>This study aims to prospectively enroll a minimum of 700 subjects, with gross or microscopic hematuria. Each site will target enrollment of 100 subjects and patient samples will be collected from consecutive patients meeting the inclusion criteria outlined below. The total study duration is expected to be 24 months. | Diagnostic Test: AssureMDx<br>* combined panel of methylation and mutation markers for the detection of bladder cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year |