Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
Study NCT ID:
NCT02092259
Status:
UNKNOWN
Last Update Posted:
2015-07-14
First Post:
2014-03-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'lastUpdateSubmitDate': '2015-07-10', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, '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', 'description': 'Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Norovirus Assay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Gastroenteritis']}, 'descriptionModule': {'briefSummary': 'The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.\n\nThe purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.', 'detailedDescription': 'The ARIES Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.\n\nThe objective is to establish the diagnostic accuracy of the ARIES Norovirus assay through a multi-site, method comparison on prospectively collected leftover, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All comers', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The specimen is from a patient with symptoms of acute gastroenteritis.\n* The specimen is from a male or female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.\n* The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.\n\nExclusion Criteria:\n\n* The specimen is from an individual with known and documented non-infectious conditions such as ulcerative colitis, irritable bowel syndrome and/or Crohn's disease\n* The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor."}, 'identificationModule': {'nctId': 'NCT02092259', 'briefTitle': 'A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luminex Molecular Diagnostics'}, 'officialTitle': 'A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay in Patients With Signs and Symptoms of Acute Gastroenteritis', 'orgStudyIdInfo': {'id': 'LMA-NOR-01-CS-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '90049', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janet Hindler', 'role': 'CONTACT', 'email': 'jhindler@mednet.ucla.edu'}, {'name': 'Romney Humphries, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '13123', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'C. Robinson', 'role': 'CONTACT', 'email': 'Christine.Robinson@childrenscolorado.org'}, {'name': 'Christine Robinson, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristin Post', 'role': 'CONTACT', 'email': 'kpost@iuhealth.org'}, {'name': 'Liang Cheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elena Popowitch', 'role': 'CONTACT', 'email': 'elena.popowitch@unchealth.unc.edu'}, {'name': 'Melissa Miller, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '17822-0131', 'city': 'Danville', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'D. Hernandez', 'role': 'CONTACT', 'email': 'drhernandez@geisinger.edu'}, {'name': 'Donna M Wolk, Ph.D.,D(ABMM)', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Geisinger Medical Laboratories', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'centralContacts': [{'name': 'Ian Ridd', 'role': 'CONTACT', 'email': 'iridd@luminexcorp.com'}], 'overallOfficials': [{'name': 'David Himsworth', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Luminex Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luminex Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}