Determination of Prostate-specific Antigen in Capillary Blood (PSA-Cap)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Accuracy of PSA measurement in capillary blood vs. venous blood
Study Overview
Brief Summary
The aim of the PSA-Cap study is to test the comparability of measurements of total PSA in serum from venipuncture and in serum from capillary blood using anonymized diagnostic blood samples from patients. Furthermore, a stability test of the samples is carried out after storage at room temperature for 24, 72/96 and 168 hours. Particular attention is paid to the comparability of the measurement results and the influence of the transportation time.
Detailed Description
Interventions that are conducted with the PSA-Cap trial are the collection of capillary blood (6 droplets) from the fingertip during regular PSA testing in venous blood. PSA is measured in the serum fraction of both samples (capillary and venous) using the established routine procedure, either immediately or after simulation of common transport conditions (intermediate storage for 24; 72/96 h and 168 h at 22 °C). Control measurements include parameters of cell lysis (LDH, HIL check) and general protein stability (albumin). The patient samples used are anonymized at the source by means of a consecutive series of numbers. The anonymized result groups are compared.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men aged from 45 to 70 years
- •Informed consent for PSA measurement for prostate cancer screening
Exclusion Criteria
- •Patients unable to give consent
Outcomes
Primary Outcomes
Accuracy of PSA measurement in capillary blood vs. venous blood
Time Frame: After 0 h, 1 d, 3/4 d and 7 d
Secondary Outcomes
- PSA stability in serum fraction of both samples (capillary and venous)(After 0 h, 1 d, 3/4 d and 7 d)
Investigators
Dr. med. Rouvier Al-Monajjed
Oberarzt
Heinrich-Heine University, Duesseldorf