Bladder Cancer Clinical Trial
Official title:
Multi Institutional Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples From A Cohort Of Patients With Hematuria
Verified date | March 2019 |
Source | MDx Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 1148 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
MDx Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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