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4Kscore Using Serum Stored Uncentrifuged

NCT04130776 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2019-10-17

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • James Ryan Mark · Thomas Jefferson University

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-04
Primary Completion
2018-03-27
Completion
2018-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04130776 on ClinicalTrials.gov