4Kscore Using Serum Stored Uncentrifuged

October 15, 2019 updated by: OPKO Health, Inc.

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

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

Study Overview

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study population will be 40 to 80 years old male whom have met all eligibility criteria

Description

Inclusion Criteria:

  • Men capable of donating five 5 mL tubes of whole blood
  • 40 to 80 years old
  • No prior diagnosis of prostate cancer; prior negative prostate biopsy included
  • Total PSA (tPSA) value measured within last year to be: at 1.5 ng/mL to 4 ng/mL, 4.1 ng/mL to 10 ng/mL and 10 ng/mL and above

Exclusion Criteria:

  • In the previous 96 hours (4 days), underwent a digital rectal exam
  • Any invasive urologic procedure in the 6 months prior to study participation
  • Underwent any procedure to treat symptomatic benign prostatic hyperplasia in the last 6 months
  • Radical prostatectomy since tPSA measurement
  • Received within the previous 6 months 5-alpha reductase inhibitor (5-ARI) therapy such as Avodart (dutasteride) or Proscar (finasteride)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tPSA changes in 3 days
Time Frame: Day 0, 1, 2 and 3
Measure tPSA in serum samples at day 0, 1, 2 and 3
Day 0, 1, 2 and 3
fPSA changes in 3 days
Time Frame: Day 0, 1, 2 and 3
Measure fPSA in serum samples at day 0, 1, 2 and 3
Day 0, 1, 2 and 3
iPSA changes in 3 days
Time Frame: Day 0, 1, 2 and 3
Measure iPSA in serum samples at day 0, 1, 2 and 3
Day 0, 1, 2 and 3
hK2 changes in 3 days
Time Frame: Day 0, 1, 2 and 3
Measure hK2 in serum samples at day 0, 1, 2 and 3
Day 0, 1, 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James Ryan Mark, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2017

Primary Completion (Actual)

March 27, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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