NCT06626386

Determination of Prostate-specific Antigen in Capillary Blood (PSA-Cap)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: Male
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PSA testing	PSA Testing in venipunctate and capillary blood

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-09-30
• Completion: 2024-10-31
• First posted: 2024-10-03
• Last updated: 2024-10-03

Locations

1 site across 1 country: Germany