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

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06626386
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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 Timeline

• Study Start: 2024-06-01
• Primary Completion: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of PSA measurement in capillary blood vs. venous blood	After 0 h, 1 d, 3/4 d and 7 d

Secondary Outcome Measures

Name	Time	Method
PSA stability in serum fraction of both samples (capillary and venous)	After 0 h, 1 d, 3/4 d and 7 d

Trial Locations

Locations (1)

Klinik für Urologie, Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, North Rhine-Westphalia, Germany