Altered PSA Test Due to Possible Suspected Heterophilic Antibodies

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02455466

Enrollment

Registered

2015-05-27

Start date

2015-03-31

Completion date

2016-12-31

Last updated

2017-05-31

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

Conditions

PSA

Brief summary

The purpose of this study is to investigate if clinically non explainable high or low Prostate-specific antigen (PSA) levels are associated with heterophilic antibodies in the serum of participants. The investigators will examine if heterophilic antibodies are the reasons of altered PSA levels.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

40 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Male, with a a clinically high or low unexplainable PSA measurement * Age between 40 and 90 years * Written informed consent

Exclusion criteria

* Female * No PSA measurement available or planned * Age over 90 or under 40 years

Design outcomes

Primary

Measure	Time frame	Description
Presence of heterophilic antibodies in the serum of participants	1.5 years	Heterophilic antibodies will be measured in the Blood serum of participants by sandwich Elisa assay
Altered PSA levels due to the Presence of Heterophilic antibodies	1.5 years	If heterophilic antibodies were present in the serum of the participant, another PSA test will be ran after absorbance of heterophilic antibodies to investigate whether PSA levels are changed without the presence of heterophilic antibodies

Countries

Switzerland

Outcome results