Multi Institutional Study in Patient Presenting With Hematuria

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03122964

Enrollment

1148

Registered

2017-04-21

Start date

2017-03-31

Completion date

2020-02-28

Last updated

2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Hematuria

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.

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.

Interventions

DIAGNOSTIC_TESTAssureMDx

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026