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The purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| men scheduled for prostate biopsy |
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| Measure | Description | Time Frame |
|---|---|---|
| ability of whole blood gene expression to predict biopsy outcome | pre-biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of tumor aggressiveness using whole blood gene expression | post-biopsy |
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Inclusion Criteria:.
Male over the age of 40.
Patient is scheduled for prostate biopsy for one or more of the following reasons:
No prior history of prostate cancer or prostate biopsy.
Exclusion Criteria:
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Men scheduled for a prostate biopsy
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| Name | Affiliation | Role |
|---|---|---|
| William Oh, MD | Mt. Sinai School of Medicine | Principal Investigator |
| Danute "Bunki" Bankaitis-Davis, PhD | Source MDx | Principal Investigator |
| Lisa Siconolfi, PhD | Source MDx | Principal Investigator |
| Philip Kantoff, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Bernardino Urological Associates | San Bernardino | California | 92404 | United States | ||
| The Urology Center of Colorado |
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whole blood for gene expression analysis
serum
plasma
| Denver |
| Colorado |
| 80211 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University Brady Urological Institute | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital/ Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Bay State Clinical Trials | Watertown | Massachusetts | 02472 | United States |
| University of Michigan | Ann Arbor | Michigan | 48105 | United States |
| Karmanos Cancer Institute Wayne State University | Detroit | Michigan | 48201 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University Urology Associates | New York | New York | 10016 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| Urology San Antonio Research | San Antonio | Texas | 78229 | United States |
| University of Washington Department of Urology | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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