- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03122964
Multi Institutional Study in Patient Presenting With Hematuria
Multi Institutional Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples From A Cohort Of Patients With Hematuria
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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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combined panel of methylation and mutation markers for the detection of bladder cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria.
Time Frame: 1 year
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Early detection of bladder cancer in patients presenting with hematuria
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hematuria
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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