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Test Semiquantitative Prostate Specific Antigen (PSA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853710
First Posted: March 2, 2009
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut Curie
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of a Semiquantitative Screening Assay for PSA

Resource links provided by NLM:


Further study details as provided by Institut Curie:

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 ]

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 ]

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)
Arms Assigned Interventions
Experimental: rapid PSA assay on whole blood 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853710


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

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT00853710     History of Changes
Other Study ID Numbers: ID RCB 2008-A01497-48
CRH 08/459/MN
First Submitted: February 24, 2009
First Posted: March 2, 2009
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Institut Curie:
Prostate-Specific Antigen
Prostate Cancer
Cancer
Assay

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