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Test Semiquantitative Prostate Specific Antigen (PSA)

This study has been completed.
Sponsor:
Collaborator:
TANAKA
Information provided by:
Centre Rene Huguenin
ClinicalTrials.gov Identifier:
NCT00853710
First received: February 24, 2009
Last updated: August 4, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
Prostatic Neoplasms
Prostatic Diseases
 Other: PSA assay

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Validation of a Semiquantitative Screening Assay for PSA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Rene Huguenin:

Primary Outcome Measures:
  • 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. [ Time Frame: day of test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement. [ Time Frame: at the last inclusion ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: March 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: PSA assay
    rapid prostate specific antigen 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853710

Locations
France
Centre Rene Huguenin
Saint Cloud, France, 92210
Sponsors and Collaborators
Centre Rene Huguenin
TANAKA
Investigators
Principal Investigator: Dominique BELLET, Pr Centre Rene Huguenin
  More Information

No publications provided

Responsible Party: Pr Jean-Nicolas Munck, General Director, Centre René Huguenin
ClinicalTrials.gov Identifier: NCT00853710     History of Changes
Other Study ID Numbers: ID RCB 2008-A01497-48, CRH 08/459/MN
Study First Received: February 24, 2009
Last Updated: August 4, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Rene Huguenin:
Prostate-Specific Antigen
Prostate Cancer
Cancer
Assay

Additional relevant MeSH terms:
Neoplasms
Prostatic Diseases
Prostatic Neoplasms
Genital Diseases, Male
 Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 23, 2013