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

H

Heinrich-Heine University, Duesseldorf

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Diagnostic Test: PSA testing

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Male

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Martin Wallisch

Data sourced from clinicaltrials.gov

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