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Analysis of Cell-free DNA (cfDNA) in Men With Elevated PSA Levels

NCT02771769 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-01-18

No results posted yet for this study

Summary

This is a multi-centre prospective study in which blood samples will be taken from 1500 male patients aged between 21-80 scheduled for prostate biopsy. Analysis of cell-free cancer DNA extracted from these samples will be undertaken to determine whether copy number instability scores derived from the cfDNA correlates with PSA screening levels and prostate biopsy results (i.e. Gleason score) in these patients.

Conditions

  • Prostatic Neoplasms

Interventions

OTHER

blood draw

Participants will have a venous blood draw of \~20mLs before prostate biopsy. The biopsy will then be performed and histologically graded for any malignancy present. This grade will be statistically analyzed with respect to the Copy Number Instability (CNI) determined from the results of the molecular examination of the cell-free DNA in the blood.

Sponsors & Collaborators

  • Smerud Medical Research International AS

    collaborator OTHER

  • Vanderbilt University

    collaborator OTHER

  • Chronix Biomedical Corporation

    lead INDUSTRY

Principal Investigators

  • David F Penson, MD · Vanderbilt University

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • United States

Study Locations

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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 NCT02771769 on ClinicalTrials.gov