NCT02455466

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

May 11, 2015

Last Update Submit

May 29, 2017

Conditions

PSA

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age40 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male, where a PSA measurement is planned

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zürich

Zurich, 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum of patients

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 27, 2015

Study Start

March 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

CH(1)