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The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged | Diagnostic Test | The 4Kscore Test helps clarify the biopsy decision-making process by determining a patient specific probability for finding aggressive, Gleason score 7 or higher prostate cancer upon biopsy. These are the aggressive prostate cancers that always require medical treatment or intervention. The 4Kscore Test relies on the measurement of four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, digital rectal exam (nodules, no nodules), and prior negative biopsy (yes, no) to give physicians a personal score for each patient. The 4Kscore Test predicts the risk percent score from <1% to >95% of a man having aggressive cancer in a prospective biopsy. |
| Measure | Description | Time Frame |
|---|---|---|
| tPSA changes in 3 days | Measure tPSA in serum samples at day 0, 1, 2 and 3 | Day 0, 1, 2 and 3 |
| fPSA changes in 3 days | Measure fPSA in serum samples at day 0, 1, 2 and 3 | Day 0, 1, 2 and 3 |
| iPSA changes in 3 days | Measure iPSA in serum samples at day 0, 1, 2 and 3 | Day 0, 1, 2 and 3 |
| hK2 changes in 3 days | Measure hK2 in serum samples at day 0, 1, 2 and 3 | Day 0, 1, 2 and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be 40 to 80 years old male whom have met all eligibility criteria
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| Name | Affiliation | Role |
|---|---|---|
| James Ryan Mark | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |