Multi Institutional Study in Patient Presenting With Hematuria

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03122964
• Other study ID #: Hematuria
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Hematuria
• Urinary Bladder Neoplasms

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