capstone program 1 oakland university william beaumont oakland.edu/medicine 1
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CAPSTONE PROGRAM1
OAKLAND UNIVERSITY WILLIAM BEAUMONT
oakland.edu/medicine
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Clinical Utility of ConfirmMDx for Prostate Cancer in Management
of Suspected Prostate Cancer
1Thanh Huynh, 2Jason Hafron, MD
1Oakland University William Beaumont School of Medicine2William Beaumont Department of Urology
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What is the clinical utility of the ConfirmMDx Test for Prostate
Cancer, i.e. do the results of the test change frequency of repeat
biopsies, follow-up visits, and prostate-specific antigen tests?
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Introduction
• Prostate cancer is one of the most common cancers in men
• Prostate-specific antigen tests (PSA), digital rectal exams (DRE), and prostate biopsies are methods of screening and detection
• ConfirmMDx (MDxHealth, Inc, Irvine CA) is an epigenetic assay that helps confirm negative biopsy.
• Will ConfirmMDx results decrease future clinical tests?
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Background
• ConfirmMDx for Prostate Cancer is a relatively new test, having come out in May 2012
• Several studies have shown the effectiveness of using epigenetic assays to detect prostate cancer not seen on biopsy1, 2
• One study has shown that ConfirmMDx reduced the rate of repeat prostate biopsies in clinical practice3
• Since ConfirmMDx is a new test, more studies are needed to confirm its clinical utility.
• Want to look at other parameters other than biopsies, such as repeat office visits and PSAs to see if test has clinical utility
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Methods
• Retrospective chart review. • Compare 3 different populations using data collected
from charts of patients at the Michigan Institute of Urology: 1) control group with negative biopsies and no ConfirmMDx test2) negative biopsies with negative ConfirmMDx tests 3) positive biopsies with positive ConfirmMDx tests
• Compare differences between the groups in terms of follow-up visits, biopsies, and PSAs
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MethodsTools/Forms of Analysis
• Use statistical tests to compare treatment in the three groups
• Sample size limited due to the number of patients/charts available to analyze
• Collecting demographic data (age, race, BMI, family history) and clinical data (DRE, PSA, biopsy findings and their dates)
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Challenges/Solutions/Limitations
• Small sample size (~50-100 patients per group) may not be enough data to prove trends in physician behavior
• Using data from one source (Michigan Institute of Urology)
• Limited follow-up times• Ideally, all three groups would be matched
for the main risk factors (e.g. age, race, PSA at biopsy, etc.)
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Results
• Results pending• Hope to find that ConfirmMDx increases
clinical by decreasing the number of follow-up visits, prostate specific antigen tests, and prostate biopsies.
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Concluding Remarks and Discussion
• Most of data has been collected and hoping to perform analysis soon
• ConfirmMDx test could help reduce the number of clinical tests done after biopsy, preventing repeat testing and saving money
• Future work could include larger sample sizes with better matching between groups, and more follow-up time
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• Ayad Khourdaji, MD and Jessica Gibson (MDxHealth)for help with data collection
• MIU Men’s Health Foundation Jeff Murri Scholarship
Acknowledgements
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References1. Stewart G, Van Neste L, Delvenne P, et al. Clinical utility of a multiplexed epigenetic gene assay to detect occult cancer in histopathologically negative prostate biopsies: results of the multicenter MATLOC study. J Urol. 2013; 189: 1110-16.
2. Van Neste L, Herman JG, Otto G, et al. The epigenetic promise for prostate cancer diagnosis. Prostate. 2012; 72: 1248-1261.
3. Wojno KJ, Costa FJ, Cornell RJ, et al. Reduced rate of biopsies observed in ConfirmMDx clinical utility field study. Am Health Drug Benefits. 2014; 7(3): 129-134.
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