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

Last updated: October 2, 2024
Sponsor: Heinrich-Heine University, Duesseldorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

PSA testing

Clinical Study ID

NCT06626386
006
  • Ages 45-70
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men aged from 45 to 70 years

  • Informed consent for PSA measurement for prostate cancer screening

Exclusion

Exclusion Criteria:

  • Patients unable to give consent

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: PSA testing
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
October 31, 2024

Study 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.

Connect with a study center

  • Klinik für Urologie, Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia 40225
    Germany

    Active - Recruiting

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