Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-30 @ 3:01 AM
Study NCT ID:
NCT01605695
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2012-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Human Plasma Level of iNOS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'heparinized plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-23', 'studyFirstSubmitDate': '2012-05-16', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the normal healthy human reference range for plasma iNOS', 'timeFrame': 'At time of blood donation', 'description': "The primary endpoint is the determination of the normal human plasma level of iNOS as the reference interval of the mean and it's 95% confidence interval. ."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['reference range', 'plasma', 'inducible nitric oxide synthase', 'iNOS', 'healthy adults'], 'conditions': ['Normal Human Plasma Level of iNOS']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'How to Define and Determine Reference Intervals in the Clinical Laboratory - Approved Guidelines, Second Edition, C28 A2, Vol 20, No. 3.'}]}, 'descriptionModule': {'briefSummary': 'The discovery that inducible nitric oxide synthase (iNOS) circulates in people who are developing the sepsis pathology has provided an opportunity to develop a first-in-class diagnostic test for the onset of sepsis. This study is designed to determine the normal human plasma level of circulating iNOS as the initial reference level against which hospitalized patients at risk for the development of sepsis can be compared to ascertain if the patient is at risk for becoming septic based upon an elevated level of plasma iNOS.', 'detailedDescription': 'Infections in intensive care units (ICUs) and other hospital settings can be caused by different types of organisms, such as bacteria and fungi. Yearly, these infections cause at least 2 million patients in the USA to enter the early stages of the sepsis pathology (pre-sepsis) which will lead to more than 750,000 cases of sepsis that can deteriorate into life-threatening severe sepsis with organ dysfunction and septic shock with multiple organ failure and result in more than 250,000 deaths per year. At present, an accurate clinical lab test to predict the onset of the sepsis pathology does not exist. Thus, there is a large unmet clinical lab need for a test that can aid physicians in assessing the risk their hospitalized patients have for developing the sepsis pathology. A reliable test for predicting very early the onset of sepsis would be a major medical breakthrough. However, a reference level for normal healthy individuals is needed against which plasma levels can be compared for increased (or decreased) levels of iNOS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Reference values will be obtained from 100 plasma samples obtained from healthy normal humans collected prospectively under an IRB approved protocol and informed consent after blood donation for use in research. The 100 normal human plasma samples will be assayed using the PliNOSa test.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Aged 18-79 years of age\n* In generally good health\n\nExclusion Criteria:\n\n* Cannot be a prisoner'}, 'identificationModule': {'nctId': 'NCT01605695', 'briefTitle': 'Normal Human Plasma Level of iNOS Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Research & Diagnostic Antibodies'}, 'officialTitle': 'Determination of the Normal Human Plasma Level of Inducible Nitric Oxide Synthase (iNOS) Using the PliNOSa Test', 'orgStudyIdInfo': {'id': 'RDAbs 12-002'}, 'secondaryIdInfos': [{'id': '1RC3GM093717-01', 'link': 'https://reporter.nih.gov/quickSearch/1RC3GM093717-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal healthy adults', 'description': 'The concentration of iNOS will be measured in plasma samples obtained at the time of blood donation from normal healthy adult humans'}]}, 'contactsLocationsModule': {'locations': [{'zip': '89032', 'city': 'North Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research & Diagnostic Antibodies', 'geoPoint': {'lat': 36.19886, 'lon': -115.1175}}], 'overallOfficials': [{'name': 'Robert J Webber, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research & Diagnostic Antibodies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research & Diagnostic Antibodies', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President and Project PI', 'investigatorFullName': 'Dr. Robert Webber', 'investigatorAffiliation': 'Research & Diagnostic Antibodies'}}}}