NCT04130776

4Kscore Using Serum Stored Uncentrifuged

Demonstrating the Stability of the Analytes Measured for 4Kscore: Total PSA (tPSA), Free PSA (fPSA), Intact PSA (iPSA), and Human Kallikrein 2 (hk2) in Clinical Serum Samples Stored Uncentrifuged Before Testing

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: —

Summary

The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged	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.

Timeline

• Start date: 2017-10-04
• Primary completion: 2018-03-27
• Completion: 2018-10-31
• First posted: 2019-10-17
• Last updated: 2019-10-17

Locations

1 site across 1 country: United States