PSANCT02455466
Altered PSA Test Due to Possible Suspected Heterophilic Antibodies
An observational study of PSA, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- PSA
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male, where a PSA measurement is planned
Who may be able to join
- Male, with a a clinically high or low unexplainable PSA measurement
- Age between 40 and 90 years
- Written informed consent
Who cannot join
- Female
- No PSA measurement available or planned
- Age over 90 or under 40 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- PSA
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of heterophilic antibodies in the serum of participants
Heterophilic antibodies will be measured in the Blood serum of participants by sandwich Elisa assay
Measured: 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
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMar 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: not enough recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSAStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455466
- Sponsor's protocol ID
- 2014-0652
- Status last verified
- May 2017
- First submitted
- 11 May 2015
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered PSA Test Due to Possible Suspected Heterophilic Antibodies
- ClinicalTrials.gov ID
- NCT02455466
- Acronym / sponsor ID
- 2014-0652
- Conditions
- PSA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not enough recruitment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male, where a PSA measurement is planned
Key inclusion criteria (3 listed)
- Male, with a a clinically high or low unexplainable PSA measurement
- Age between 40 and 90 years
- Written informed consent
Key exclusion criteria (3 listed)
- Female
- No PSA measurement available or planned
- Age over 90 or under 40 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of heterophilic antibodies in the serum of participants
Time frame: 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
Time frame: 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
Results and safety
The study was stopped early (reason given: not enough recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PSA, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not enough recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of heterophilic antibodies in the serum of participants (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.