Clinical trial · Interventional
Test Semiquantitative Prostate Specific Antigen (PSA)
Validation of a Semiquantitative Screening Assay for PSA
NCT00853710CI-TRIAL-00097643completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Diseases | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSA assay | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rapid PSA assay on whole blood
- interventionNames
- Other: PSA assay
Primary outcomes (1)
- 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.
- timeFrame
- day of test
Secondary outcomes (1)
- measure
- Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.
- timeFrame
- at the last inclusion
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.