Altered PSA Test Due to Possible Suspected Heterophilic Antibodies

PSA Clinical Trial

Official title:

Altered PSA Test Due to Possible Suspected Heterophilic Antibodies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02455466
• Other study ID #: 2014-0652
• Status: Terminated
• Phase: N/A
• First received: May 11, 2015
• Last updated: May 29, 2017
• Start date: March 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• PSA

Locations

Country	Name	City	State
Switzerland	University Hospital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of heterophilic antibodies in the serum of participants	Heterophilic antibodies will be measured in the Blood serum of participants by sandwich Elisa assay	1.5 years
Primary	Altered PSA levels due to the Presence of Heterophilic antibodies	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	1.5 years