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4Kscore Using Serum Stored Uncentrifuged | Clinical Trials | Clareo Health

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COMPLETEDNCT04130776

4Kscore Using Serum Stored Uncentrifuged

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

Lead sponsor: OPKO Health, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

OPKO Health, Inc.

Age

40 - 80 years

Sex

MALE

Healthy Volunteers

No

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 17, 2019Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment64

Start dateOct 2017

Last updatedOct 17, 2019

Condition

Prostate Cancer

Locations shown

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2019Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions