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Multi Institutional Study in Patient Presenting With Hematuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03122964
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
MDx Health

Tracking Information
First Submitted Date April 12, 2017
First Posted Date April 21, 2017
Last Update Posted Date March 6, 2019
Actual Study Start Date March 31, 2017
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2017)
Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria. [ Time Frame: 1 year ]
Early detection of bladder cancer in patients presenting with hematuria
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03122964 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 20, 2017)
Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer. [ Time Frame: 1 year ]
Accurately predict clinical risk of bladder cancer through clinical factors and methylation markers
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi Institutional Study in Patient Presenting With Hematuria
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
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subject presents with or has a history of gross hematuria or micro hematuria within the last 3 months
Condition
  • Bladder Cancer
  • Hematuria
Intervention Diagnostic Test: AssureMDx
combined panel of methylation and mutation markers for the detection of bladder cancer
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: AssureMDx
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 5, 2019)
1148
Original Estimated Enrollment
 (submitted: April 20, 2017)
700
Estimated Study Completion Date February 28, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03122964
Other Study ID Numbers Hematuria
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party MDx Health
Study Sponsor MDx Health
Collaborators Not Provided
Investigators Not Provided
PRS Account MDx Health
Verification Date March 2019