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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06626386
Acronym
PSA-Cap
Enrollment
200
Registered
2024-10-03
Start date
2024-06-01
Completion date
2024-10-31
Last updated
2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Prostate specific Antigen

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.

Interventions

DIAGNOSTIC_TESTPSA testing

PSA Testing in venipunctate and capillary blood

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
MALE
Age
45 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Accuracy of PSA measurement in capillary blood vs. venous bloodAfter 0 h, 1 d, 3/4 d and 7 d

Secondary

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

Countries

Germany

Contacts

Primary ContactMartin Wallisch
martin.wallisch@med.uni-duesseldorf.de+49 015751187144

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026