Multi Institutional Study in Patient Presenting With Hematuria
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ClinicalTrials.gov Identifier: NCT03122964 |
Recruitment Status : Unknown
Verified March 2019 by MDx Health.
Recruitment status was: Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : March 6, 2019
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Condition or disease | Intervention/treatment |
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Bladder Cancer Hematuria | Diagnostic Test: AssureMDx |
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 Type : | Observational |
Actual Enrollment : | 1148 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | March 31, 2017 |
Estimated Primary Completion Date : | February 28, 2020 |
Estimated Study Completion Date : | February 28, 2020 |

Group/Cohort | Intervention/treatment |
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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.
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Diagnostic Test: AssureMDx
combined panel of methylation and mutation markers for the detection of bladder cancer |
- Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria. [ Time Frame: 1 year ]Early detection of bladder cancer in patients presenting with hematuria
- Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer. [ Time Frame: 1 year ]Accurately predict clinical risk of bladder cancer through clinical factors and methylation markers

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Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122964
United States, Texas | |
UT Southwestern | |
Dallas, Texas, United States, 75390 |
Responsible Party: | MDx Health |
ClinicalTrials.gov Identifier: | NCT03122964 |
Other Study ID Numbers: |
Hematuria |
First Posted: | April 21, 2017 Key Record Dates |
Last Update Posted: | March 6, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Urinary Bladder Neoplasms Hematuria Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms |
Urinary Bladder Diseases Urologic Diseases Urination Disorders Hemorrhage Pathologic Processes |