Multi Institutional Study in Patient Presenting With Hematuria

• Conditions: Hematuria; Bladder Cancer
• Interventions: Diagnostic Test: AssureMDx

• Registration Number: NCT03122964
• Lead Sponsor: MDx Health

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 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.

Study Timeline

• Study Start: 2017-03-31
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1148

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with gross or microscopic hematuria	AssureMDx	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.

Primary Outcome Measures

Name	Time	Method
Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria.	1 year	Early detection of bladder cancer in patients presenting with hematuria

Secondary Outcome Measures

Name	Time	Method
Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer.	1 year	Accurately predict clinical risk of bladder cancer through clinical factors and methylation markers

Trial Locations

Locations (1)

UT Southwestern; 🇺🇸 Dallas, Texas, United States