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Multi Institutional Study in Patient Presenting With Hematuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03122964
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
MDx Health

Brief Summary:
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.

Condition or disease Intervention/treatment
Bladder Cancer Hematuria Diagnostic Test: AssureMDx

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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.
Diagnostic Test: AssureMDx
combined panel of methylation and mutation markers for the detection of bladder cancer




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
Study Population
Subject presents with or has a history of gross hematuria or micro hematuria within the last 3 months
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
MDx Health

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Responsible Party: MDx Health
ClinicalTrials.gov Identifier: NCT03122964     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Hematuria
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Urination Disorders
Hemorrhage
Pathologic Processes