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BRIEF TITLE: Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples ... Of Patients 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


  • Org Study ID: Hematuria
  • Secondary ID:
  • NCT ID: NCT03122964
  • NCT Alias:
  • Sponsor: MDx Health - Industry
  • Source: MDx Health

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.

Overal Status Start Date Phase Study Type
Recruiting March 31, 2017 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria.

Primary Outcome 1 - Time Frame: 1 year

Condition:

  • Bladder Cancer
  • Hematuria

Eligibility

Criteria:
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
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Gender: All

Minimum Age: 40 Years

Maximum Age: 85 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Name: Jessica DeHart, MS

Phone: (866) 259-5644

Email: jessica.dehart@mdxhealth.com

Location

Facility Status Contact
UT Southwestern
Dallas, Texas 75390
United States
Recruiting Allison Beaver

Allison.Beaver@UTSouthwestern.edu