Multi Institutional Study in Patient Presenting With Hematuria
NCT ID: NCT03122964
Last Updated: 2019-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1148 participants
OBSERVATIONAL
2017-03-31
2020-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with gross or microscopic hematuria
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.
AssureMDx
combined panel of methylation and mutation markers for the detection of bladder cancer
Interventions
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AssureMDx
combined panel of methylation and mutation markers for the detection of bladder cancer
Eligibility Criteria
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Inclusion Criteria
2. Subject presents with or has a history of gross hematuria or microhematuria within the last 3 months
Exclusion Criteria
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
40 Years
85 Years
ALL
Yes
Sponsors
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MDx Health
INDUSTRY
Responsible Party
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Locations
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UT Southwestern
Dallas, Texas, United States
Countries
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Other Identifiers
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Hematuria
Identifier Type: -
Identifier Source: org_study_id
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