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Validation of a Semiquantitative Screening Assay for PSA

18 Years
Not Enrolling
Prostate Cancer, Prostatic Neoplasms, Prostatic Diseases

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Trial Information

Validation of a Semiquantitative Screening Assay for PSA

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.

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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

day of test

Safety Issue:


Principal Investigator

Dominique BELLET, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Rene Huguenin


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ID RCB 2008-A01497-48



Start Date:

March 2009

Completion Date:

July 2009

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms
  • Prostatic Diseases
  • Prostate-Specific Antigen
  • Prostate Cancer
  • Cancer
  • Assay
  • Neoplasms
  • Prostatic Diseases
  • Prostatic Neoplasms