Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-11 @ 9:22 PM
Study NCT ID:
NCT02142894
Status:
COMPLETED
Last Update Posted:
2019-06-18
First Post:
2014-05-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the QuantiFERON-TB Test.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andrew.schumacher@qiagen.com', 'phone': '301-944-7094', 'title': 'Clinical Study Coordinator', 'organization': 'QIAGEN Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From 27th May 2014 to 28th Mar 2016.', 'eventGroups': [{'id': 'EG000', 'title': 'Symptomatic', 'description': 'Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Evaluation of clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms indicating TB disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '2 x 2 contingency table', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '87.9', 'ciLowerLimit': '72.7', 'ciUpperLimit': '95.2', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The results are analyzed in a 2x2 contingency table with 95%CI.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of enrollment', 'description': 'To evaluate the clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms strongly indicating TB disease and who are receiving or have to start treatment for active TB, and whom Mycobacterium tuberculosis (MTB) is confirmed by bacteriological culture. Patients included in the testing either had a positive acid-fast bacillus (AFB) smear of have MTB in a specimen detected by nucleic acid amplification (NAA) of MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symptomatic', 'description': 'Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.\n\nCST001'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': 'A total of 33 subjects were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Symptomatic', 'description': 'Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.\n\nCST001'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2016-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2014-05-16', 'resultsFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-27', 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity', 'timeFrame': 'At time of enrollment', 'description': 'To evaluate the clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms strongly indicating TB disease and who are receiving or have to start treatment for active TB, and whom Mycobacterium tuberculosis (MTB) is confirmed by bacteriological culture. Patients included in the testing either had a positive acid-fast bacillus (AFB) smear of have MTB in a specimen detected by nucleic acid amplification (NAA) of MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tuberculosis', 'TB'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.'}]}, 'descriptionModule': {'briefSummary': 'To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.', 'detailedDescription': 'The objective of the study was to enroll patients who have clinical signs/symptoms strongly indicating TB and who are receiving of have to start the treatment for active TB, and test the variants of the CST001 assay to support the evaluation of clinical sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with bacteriologically confirmed and untreated TB disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical symptoms consistent with a high probability of having TB disease\n* Receiving, or are likely to receive, therapy for active TB\n* Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing.\n* Between 18 and 70 years of age.\n\nExclusion Criteria:\n\n* Taken therapy for active TB or latent TB for more than 14 days\n* Culture confirmation of M. tuberculosis not obtained'}, 'identificationModule': {'nctId': 'NCT02142894', 'briefTitle': 'Evaluation of the QuantiFERON-TB Test.', 'organization': {'class': 'INDUSTRY', 'fullName': 'QIAGEN Gaithersburg, Inc'}, 'officialTitle': 'Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection', 'orgStudyIdInfo': {'id': 'CST001_USA1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Symptomatic', 'description': 'Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.', 'interventionNames': ['Device: CST001']}], 'interventions': [{'name': 'CST001', 'type': 'DEVICE', 'armGroupLabels': ['Symptomatic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Brenda Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QIAGEN Gaithersburg, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}