Test Semiquantitative Prostate Specific Antigen (PSA)

Prostate Cancer Clinical Trial

Official title:

Validation of a Semiquantitative Screening Assay for PSA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853710
• Other study ID #: ID RCB 2008-A01497-48
• Secondary ID: CRH 08/459/MN
• Status: Completed
• Phase: N/A
• First received: February 24, 2009
• Last updated: August 25, 2017
• Start date: March 2009
• Est. completion date: July 2009

Study information

• Verified date: August 2017
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated.

• Patients must have given informed consent.

Exclusion Criteria:

• Patients followed for a disease other than prostatic.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Diseases
• Prostatic Neoplasms

Intervention

Other:
• PSA assay
rapid prostate specific antigen assay.

Locations

Country	Name	City	State
France	Centre Rene Huguenin	Saint Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the sensitivity and specificity of the rapid PSA assay by comparing the results obtained from the test strip reading by three independent blinded observers with those from standard plasma PSA assay.		day of test
Secondary	Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.		at the last inclusion