Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-30 @ 3:17 AM
Study NCT ID:
NCT02009735
Status:
UNKNOWN
Last Update Posted:
2013-12-16
First Post:
2012-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-12', 'studyFirstSubmitDate': '2012-12-26', 'studyFirstSubmitQcDate': '2013-12-11', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influenza virus or Enterovirus 71 detection', 'timeFrame': '1 Day', 'description': 'In comparison with results from viral isolation and RT-PCR of influenza virus or Enterovirus 71 , we evaluate the performance of virosensor, including sensitivity, specificity, cross-reaction and reproducibility.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Enterovirus 71 and Influenza Virus'], 'conditions': ['Enterovirus 71 and Influenza Virus']}, 'descriptionModule': {'briefSummary': 'To develop a real-time diagnostic technique with Virosensor for Enterovirus 71 and Influenza Virus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Enterovirus 71 and Influenza Virus, the investigators evaluate the performance of virosensor , including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. With such technique, the investigators hope to make early diagnosis and give Enterovirus 71 and Influenza Virus patients early treatment to reduce the complications and case-fatality rate.', 'detailedDescription': "1. Sample acquirement： At National Taiwan University Hospital in Taiwan, we will enroll patients who have influenza-like illness or enterovirus infection . We will take three throat swabs for each patient: one for viral isolation, one for RT-PCR and the last for the Virosensor - based real-time diagnosis.\n2. Virosensor diagnosis： Virosensor (structural chip-based optosensing virus probing system), which is for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-influenza-virus (or anti-Enterovirus 71-virus) and its influenza virus antigen (or Enterovirus 71 antigen) present in patients'and normal samples.\n3. Gold standard： viral isolation and RT-PCR"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients with confirmed or suspected infection.\n* The healthy person without disease.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02009735', 'briefTitle': 'Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus', 'orgStudyIdInfo': {'id': '201203067RIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virosensor', 'description': 'virus detection', 'interventionNames': ['Device: virosensor']}], 'interventions': [{'name': 'virosensor', 'type': 'DEVICE', 'description': 'virosensor, which was developed for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-influenza-virus (or anti-EV71-virus) and its influenza virus antigen (or EV71 antigen) present in patients and normal samples.\n\nThe system incorporates the use of chip formats. In antibody probing, antibodies are bound as a suitable probe, which specifically and selectively binds targeted molecules (virus antigen) in the test specimens.', 'armGroupLabels': ['virosensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10051', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Luan-Yin Chang, MD,PhD', 'role': 'CONTACT', 'email': 'lychang@ntu.edu.tw', 'phone': '886-2-2312-3456', 'phoneExt': '71528'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Shiming Lin, PhD', 'role': 'CONTACT', 'email': 'til@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '88458'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}