Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2026-01-03 @ 2:49 AM
Study NCT ID:
NCT03502161
Status:
TERMINATED
Last Update Posted:
2020-09-16
First Post:
2018-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the QuantiFERON CMV Assay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Residual Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Business decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in time to CMV Infection between sub-groups of QF-CMV assay classifications.', 'timeFrame': 'At time of prophylaxis termination, +1 month from termination, +2 months from termination', 'description': 'Measurement of QF-CMV result'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CMV']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Tolkoff-Rubin N, Rubin R. The impact of cytomegalovirus infection on graft function and patient outcome. Graft 1999; 2:S101-3.'}, {'pmid': '11229841', 'type': 'BACKGROUND', 'citation': 'Singh N. Preemptive therapy versus universal prophylaxis with ganciclovir for cytomegalovirus in solid organ transplant recipients. Clin Infect Dis. 2001 Mar 1;32(5):742-51. doi: 10.1086/319225. Epub 2001 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CMV D+/R- SOT recipients older than 18 that are receiving 3-6 months of antiviral prophylaxis and can provide Informed Consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older.\n* Scheduled to receive between 3 to 6 months of antiviral prophylaxis\n* Provide Informed Consent\n\nExclusion Criteria:\n\n* Subjects less than 18 years old\n* Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis\n* Unable to provide Informed Consent'}, 'identificationModule': {'nctId': 'NCT03502161', 'briefTitle': 'Clinical Evaluation of the QuantiFERON CMV Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'QIAGEN Gaithersburg, Inc'}, 'officialTitle': 'Clinical Evaluation of the QuantiFERON CMV Assay', 'orgStudyIdInfo': {'id': 'C16-CMV-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All subjects', 'description': 'Those receiving a SOT and coming off either 3 months or 6 months of antiviral prophylaxis.', 'interventionNames': ['Device: QuantiFERON CMV Assay']}], 'interventions': [{'name': 'QuantiFERON CMV Assay', 'type': 'DEVICE', 'description': 'Assay to measure cell-mediated immune function using QuantiFERON CMV assay.', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QIAGEN Gaithersburg, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}