Clinical Evaluation of the ExoIntelliScore Prostate in men presenting for initial biopsy; impact on decision-making and health economics
Sponsor: |
Exosome Diagnostics, Inc. |
Enrolling: |
Male Patients Only |
IRB Number: |
AAAR2353 |
U.S. Govt. ID: |
NCT03031418 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The goal of this study is to evaluate how the results of a novel laboratory developed and validated urine test which predicts the likelihood of high grade prostate cancer will impact the decision on whether you will have a prostate biopsy to rule out prostate cancer. Approximately 1,000 subjects will be enrolled in this study. The study is expected to last a year. You will not receive any experimental treatments or services in this study. The treating physician will simply collect a urine sample from you before your scheduled prostate biopsy (during your established clinic visit). Based on the results of the test, you may be asked to provide an additional urine sample at 6 months from enrollment in the study.
This study is closed
Investigator
Sven Wenske, MD
Are you a man who is 50 years of age or older? |
Yes |
No |
Does your doctor suspect you have prostate cancer? |
Yes |
No |
Do you have a history of prostate cancer or renal/bladder tumors? |
Yes |
No |
Do you have hepatitis (any type) and/or HIV? |
Yes |
No |