Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-03-01 @ 10:50 PM
Study NCT ID:
NCT02455466
Status:
TERMINATED
Last Update Posted:
2017-05-31
First Post:
2015-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Altered PSA Test Due to Possible Suspected Heterophilic Antibodies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood serum of patients'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'not enough recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-29', 'studyFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of heterophilic antibodies in the serum of participants', 'timeFrame': '1.5 years', 'description': 'Heterophilic antibodies will be measured in the Blood serum of participants by sandwich Elisa assay'}, {'measure': 'Altered PSA levels due to the Presence of Heterophilic antibodies', 'timeFrame': '1.5 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['PSA']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male, where a PSA measurement is planned', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, with a a clinically high or low unexplainable PSA measurement\n* Age between 40 and 90 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Female\n* No PSA measurement available or planned\n* Age over 90 or under 40 years'}, 'identificationModule': {'nctId': 'NCT02455466', 'briefTitle': 'Altered PSA Test Due to Possible Suspected Heterophilic Antibodies', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Altered PSA Test Due to Possible Suspected Heterophilic Antibodies', 'orgStudyIdInfo': {'id': '2014-0652'}}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}