- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130776
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
Status
Completed
Conditions
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
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Sidney Kimmel Cancer Center at Thomas Jefferson University
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20622
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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