Background: Management of active surveillance (AS) in low-risk prostate cancer (PCa) patients could be improved with new biomarkers, such as the 4Kscore test. We analyze its ability to predict tumor reclassification by upgrading at the confirmatory biopsy at 6 months.
Methods: Observational, prospective, blinded, and non-randomized study, within the Spanish National Registry on AS (AEU/PIEM/2014/0001; NCT02865330) with 181 patients included after initial Bx and inclusion criteria: PSA ≤10 ng/mL, cT1c-T2a, Grade group 1, ≤2 cores, and ≤5 mm/50% length core involved.
The 4Kscore Test (OPKO Diagnostics, Woburn, MA) is a blood test utilized prior to a prostate biopsy to determine a patient's risk of high-grade prostate cancer (PCa) should the biopsy be performed, thus providing critical information in the clinical management of men with a suspicious prostate-specific antigen value or digital rectal examination result. Multiple US and European clinical studies confirmed that a prebiopsy 4Kscore Test has a high degree of discrimination for a subsequent discovery of high-grade (Gleason score ≥7) PCa. The aim of this study was to evaluate the predictive accuracy of the 4Kscore Test to discriminate between patients with and without high-grade PCa based on published clinical validation studies.
View Article and Find Full Text PDFIntroduction: The 4Kscore Test is a prebiopsy blood test that incorporates four prostate protein biomarkers along with patient clinical information to determine a man's risk for high-grade, aggressive (Gleason ≥7) prostate cancer. However, some men likely to benefit from the test may be seen in primary care settings where the digital rectal examination (DRE) information is not always obtained. In this study, we assessed the clinical validity of the 4Kscore Test when the DRE information was not included in the algorithm.
View Article and Find Full Text PDFThromb Haemost
December 2004
The study investigated the clinical usefulness of a new method to evaluate platelet activation and the variability of platelet response to anti-platelet therapy in patients undergoing percutaneous transluminal coronary angioplasty (PTCA). Platelet activation was assessed in parallel by a new method for platelet density measurements (MPC, Mean Platelet Component Concentration), on the automated ADVIA 120 Hematology System and by the classic measurement of P-selectin (CD62P) expression, on a fluorescence flow cytometer. Patients received a loading dose of clopidogrel (300 mg; n = 29) or a bolus of abciximab (0.
View Article and Find Full Text PDFJ Clin Virol
April 2004
The ability to automate immunodiagnostics testing is critical for the efficiency of clinical laboratories. For automation of Infectious Disease testing, special design considerations must be made to ensure the integrity of the testing result while at the same time delivering productivity. The ADVIA Centaur was designed with the intent of performing a complete Infectious Disease panel including HBV, HCV, and HIV markers.
View Article and Find Full Text PDFIn vivo platelet activation results are often confounded by activation induced in vitro during the preparative procedures. We measured ex vivo (basal) and in vitro (thrombin-induced) platelet activation in sodium citrate, ethylenediaminetetraacetic acid (EDTA), and Citrate Theophylline Dipyridamole Adenosine (CTAD) whole blood specimens. Determinations were made by measurements of platelet density (mean platelet component: MPC concentration) on the Advia 120 Hematology System.
View Article and Find Full Text PDFPlatelet activation is reported to correlate with acute coronary syndromes. A platelet analysis method on the ADVIA 120 Hematology System provides rapid analysis of platelet density, reported as mean platelet component (MPC) concentration, utilizes routine hematology specimens, requires no pre-treatment, and thirty seconds to generate results. Sub-populations of platelets separated by density gradients showed excellent correlation with the ADVIA 120 MPC parameter (r = 0.
View Article and Find Full Text PDFBackground: Monitoring of platelet activation by the ADVIA 120 Hematology System requires an anticoagulant and protocol that ensures that platelets are sphered and their activation status is not altered artifactually in vitro.
Methods: Blood from healthy controls was collected into tripotassium EDTA; citrate, theophylline, adenosine, and dipyridamole (CTAD); or a combination of both (E/C) and stored at ambient temperature or at 4 degrees C (E/C only) and then analyzed between 0 and 180 min later on the ADVIA 120. In addition, immunofluorescent flow cytometry was used to identify activated platelets and platelet-leukocyte aggregates.