Clinical trial · Observational
4Kscore Using Serum Stored Uncentrifuged
Demonstrating the Stability of the Analytes Measured for 4Kscore: Total PSA (tPSA), Free PSA (fPSA), Intact PSA (iPSA), and Human Kallikrein 2 (hk2) in Clinical Serum Samples Stored Uncentrifuged Before Testing
NCT04130776CI-TRIAL-00041170completedClinicalTrials.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 purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- tPSA changes in 3 days
- timeFrame
- Day 0, 1, 2 and 3
- description
- Measure tPSA in serum samples at day 0, 1, 2 and 3
- measure
- fPSA changes in 3 days
- timeFrame
- Day 0, 1, 2 and 3
- description
- Measure fPSA in serum samples at day 0, 1, 2 and 3
- measure
- iPSA changes in 3 days
- timeFrame
- Day 0, 1, 2 and 3
- description
- Measure iPSA in serum samples at day 0, 1, 2 and 3
- measure
- hK2 changes in 3 days
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Men capable of donating five 5 mL tubes of whole blood * 40 to 80 years old * No prior diagnosis of prostate cancer; prior negative prostate biopsy included * Total PSA (tPSA) value measured within last year to be: at 1.5 ng/mL to 4 ng/mL, 4.1 ng/mL to 10 ng/mL and 10 ng/mL and above Exclusion Criteria: * In the previous 96 hours (4 days), underwent a digital rectal exam * Any invasive urologic procedure in the 6 months prior to study participation * Underwent any procedure to treat symptomatic benign prostatic hyperplasia in the last 6 months * Radical prostatectomy since tPSA measurement * Received within the previous 6 months 5-alpha reductase inhibitor (5-ARI) therapy such as Avodart (dutasteride) or Proscar (finasteride)
References
Publications (0)
Data not yet available
No reference posted for this study.