NCT06626386

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 2, 2024

Last Update Submit

October 2, 2024

Conditions

Keywords

Prostate CancerProstate specific Antigen

Outcome Measures

Primary Outcomes (1)

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

    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)

    After 0 h, 1 d, 3/4 d and 7 d

Interventions

PSA testingDIAGNOSTIC_TEST

PSA Testing in venipunctate and capillary blood

Eligibility Criteria

Age45 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male patients between the ages of 40 and 70 who receive a PSA test as part of their routine examination

You may qualify if:

  • Men aged from 45 to 70 years
  • Informed consent for PSA measurement for prostate cancer screening

You may not qualify if:

  • Patients unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Urologie, Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oberarzt

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 3, 2024

Study Start

June 1, 2024

Primary Completion

September 30, 2024

Study Completion

October 31, 2024

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations