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NCT Number: NCT06626386

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Klinik für Urologie, Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location status: Recruiting

Location contact

Martin Wallisch, Dr. med

CONTACT

[email protected]

015751187144 ext. +49

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSA testing

Diagnostic Test

PSA Testing in venipunctate and capillary blood

Primary outcomes

  1. Accuracy of PSA measurement in capillary blood vs. venous blood

    Time frame: After 0 h, 1 d, 3/4 d and 7 d

Secondary outcomes

  1. PSA stability in serum fraction of both samples (capillary and venous)

    Time frame: After 0 h, 1 d, 3/4 d and 7 d

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Wallisch

CONTACT

[email protected]

+49 015751187144

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Acronym: PSA-Cap

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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