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| ID | Type | Description | Link |
|---|---|---|---|
| CRH 08/459/MN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rapid PSA assay on whole blood | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSA assay | Other | rapid prostate specific antigen assay. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement. | at the last inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique BELLET, Pr | Institut Curie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Rene Huguenin | Saint-Cloud | 92210 | France |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011469 | Prostatic Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D017430 | Prostate-Specific Antigen |
| ID | Term |
|---|---|
| D007610 | Kallikreins |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D029584 | Prostatic Secretory Proteins |
| D029589 | Seminal Plasma Proteins |
| D000094664 | Seminal Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |