Multi Institutional Study in Patient Presenting With Hematuria

Sponsor

MDx Health (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03122964

Collaborator

(none)

1,148

Enrollment

Location

Anticipated Duration (Months)

32.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Mar 31, 2017

Anticipated Primary Completion Date :

Feb 28, 2020

Anticipated Study Completion Date :

Feb 28, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria. [1 year]
Early detection of bladder cancer in patients presenting with hematuria

Secondary Outcome Measures

Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer. [1 year]
Accurately predict clinical risk of bladder cancer through clinical factors and methylation markers

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern	Dallas	Texas	United States	75390

Sponsors and Collaborators

MDx Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MDx Health

ClinicalTrials.gov Identifier:

NCT03122964

Other Study ID Numbers:

Hematuria

First Posted:

Apr 21, 2017

Last Update Posted:

Mar 6, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Hematuria

Study Results

No Results Posted as of Mar 6, 2019