NCT00853710

Test Semiquantitative Prostate Specific Antigen (PSA)

Validation of a Semiquantitative Screening Assay for PSA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.

Detailed description

Screening and surveillance of prostate cancer typically involves sensitive laboratory techniques for the quantification of plasma prostate specific antigen (PSA). In this study, we determine the sensitivity and specificity of a simple test strip based PSA assay using only a few drops of whole blood as compared to a standard plasma PSA assay. Blood samples will be taken from hundred patients who are followed for a prostatic disease needing PSA surveillance. Before decantation of the samples, a few drops of blood will serve for the rapid test on strips. Plasma PSA levels will be determined with the TRACE ("Time Resolved Amplified Cryptate Emission") technology in homogeneous liquid phase. The results from the rapid test can then be compared to the plasma levels obtained by TRACE.

Conditions

• Prostate Cancer
• Prostatic Neoplasms
• Prostatic Diseases

Interventions

Type	Name	Description
OTHER	PSA assay	rapid prostate specific antigen assay.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-03-02
• Last updated: 2025-11-20

Locations

1 site across 1 country: France