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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03122964
Other study ID # Hematuria
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 31, 2017
Est. completion date February 28, 2020

Study information

Verified date March 2019
Source MDx Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1148
Est. completion date February 28, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States UT Southwestern Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
MDx Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria. Early detection of bladder cancer in patients presenting with hematuria 1 year
Secondary Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer. Accurately predict clinical risk of bladder cancer through clinical factors and methylation markers 1 year
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