Multi Institutional Study in Patient Presenting With Hematuria
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|ClinicalTrials.gov Identifier: NCT03122964|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment|
|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|
|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|
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.
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
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|
|Dallas, Texas, United States, 75390|