Multi Institutional Study in Patient Presenting With Hematuria

March 5, 2019 updated by: MDx Health

Multi Institutional Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples From A Cohort Of Patients With Hematuria

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.

Study Overview

Status

Unknown

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

Observational

Enrollment (Actual)

1148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
combined panel of methylation and mutation markers for the detection of bladder cancer

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
Early detection of bladder cancer in patients presenting with hematuria
1 year

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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 31, 2017

Primary Completion (ANTICIPATED)

February 28, 2020

Study Completion (ANTICIPATED)

February 28, 2020

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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