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
1 other identifier
observational
1,148
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2017
CompletedFirst Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedMarch 6, 2019
March 1, 2019
2.9 years
April 12, 2017
March 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer.
1 year
Study Arms (1)
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.
Interventions
combined panel of methylation and mutation markers for the detection of bladder cancer
Eligibility Criteria
Subject presents with or has a history of gross hematuria or micro hematuria within the last 3 months
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MDx Healthlead
Study Sites (1)
UT Southwestern
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2017
First Posted
April 21, 2017
Study Start
March 31, 2017
Primary Completion
February 28, 2020
Study Completion
February 28, 2020
Last Updated
March 6, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share