Multi Institutional Study in Patient Presenting With Hematuria

MDxHealth

Status: Unknown

Conditions: Bladder Cancer; Hematuria

Treatments: Diagnostic Test: AssureMDx

Study type: Observational

Funder types: Industry

Identifiers

NCT03122964

Hematuria

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,148 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,148 participants in 1 patient group

Patients with gross or microscopic hematuria

Description:

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.

Treatment:

Diagnostic Test: AssureMDx