Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT02092233
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Patient lesion swab specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1963}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2015-07-09', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).', 'timeFrame': 'Within the first year of sample collection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ARIES HSV 1&2'], 'conditions': ['Herpes']}, 'descriptionModule': {'briefSummary': 'The ARIES HSV 1\\&2 Assay is a PCR based test for the direct detection and typing of herpes simplex virus (HSV 1 \\& 2) DNA.\n\nThe objective is to establish the diagnostic accuracy of ARIES HSV-1\\&2 Assay.', 'detailedDescription': 'The ARIES HSV 1\\&2 Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1 \\& 2) DNA in male external and internal anogenital, female external and internal anogenital (vaginal), oral and skin lesion specimens.\n\nThe objective is to establish the diagnostic accuracy of ARIES HSV-1\\&2 Assay through a multi-site, method comparison on prospectively collected, left-over de-identified, clinical specimens (i.e. all-comers accrued at enrolled clinical sites between pre-determined dates) as an aid in the diagnosis of herpes infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Clinical lesions from pediatic or adult patients suspected of having herpes infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe specimen is from one of the following lesion sources: male internal and external anogenital, female internal anogenital, female external anogenital, oral or skin The specimen is collected and maintained in unexpired Copan universal transport medium\n\nExclusion Criteria:\n\nThe specimen was not properly collected, transported or stored according to instructions provided by Sponsor'}, 'identificationModule': {'nctId': 'NCT02092233', 'briefTitle': 'A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luminex Molecular Diagnostics'}, 'officialTitle': 'A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients', 'orgStudyIdInfo': {'id': 'LMA-HSV-01-CS-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blinded, Prospective Arm', 'description': 'The diagnostic accuracy for lesions from individuals suspected of having a herpes infection will be evaluated in prospectively collected, left-over de-identified, clinical specimens accrued between pre-defined dates.'}, {'label': 'Blinded, Pre-selected Arm', 'description': 'For specimen types that are less common, banked, pre-selected, positive clinical specimens will be tested.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Tricore', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27215', 'city': 'Burlington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Labcorp', 'geoPoint': {'lat': 36.09569, 'lon': -79.4378}}], 'overallOfficials': [{'name': 'David Himsworth', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Luminex Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luminex Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}