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

NCT ID: NCT06626386

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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PSA testing

PSA Testing in venipunctate and capillary blood

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Rouvier Al-Monajjed

Oberarzt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinik für Urologie, Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Wallisch

Role: CONTACT

+49 015751187144

Facility Contacts

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Martin Wallisch, Dr. med

Role: primary

015751187144 ext. +49

Other Identifiers

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006

Identifier Type: -

Identifier Source: org_study_id

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