Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-02 @ 3:58 AM
Study NCT ID:
NCT01718535
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aazad@mtsinai.on.ca', 'phone': '416-856-8545', 'title': 'Azar Azad', 'organization': 'Mount Sinai Services Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': True, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored for the full duration of the trial (~1 months).', 'description': 'No adverse events were encountered.', 'eventGroups': [{'id': 'EG000', 'title': '*1/*1 CYP2C19 Genotype', 'otherNumAtRisk': 131, 'otherNumAffected': 0, 'seriousNumAtRisk': 131, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '*1/*2 CYP2C19 Genotype', 'otherNumAtRisk': 95, 'otherNumAffected': 0, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '*2/*2 CYP2C19 Genotype', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '*1/*3 CYP2C19 Genotype', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '*3/*3 CYP2C19 Genotype', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '*1/*17 CYP2C19 Genotype', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '*17/*17 CYP2C19 Genotype', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '*2/*3 CYP2C19 Genotype', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': '*2/*17 CYP2C19 Genotype', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': '*3/*17 CYP2C19 Genotype', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Agreement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': '*1/*1 CYP2C19 Genotype'}, {'id': 'OG001', 'title': '*1/*2 CYP2C19 Genotype'}, {'id': 'OG002', 'title': '*2/*2 CYP2C19 Genotype'}, {'id': 'OG003', 'title': '*1/*3 CYP2C19 Genotype'}, {'id': 'OG004', 'title': '*3/*3 CYP2C19 Genotype'}, {'id': 'OG005', 'title': '*1/*17 CYP2C19 Genotype'}, {'id': 'OG006', 'title': '*17/*17 CYP2C19 Genotype'}, {'id': 'OG007', 'title': '*2/*3 CYP2C19 Genotype'}, {'id': 'OG008', 'title': '*2/*17 CYP2C19 Genotype'}, {'id': 'OG009', 'title': '*3/*17 CYP2C19 Genotype'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '72', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '27', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '69', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG008', 'lowerLimit': '85', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG009', 'lowerLimit': '27', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After second pass result is complete (~3hours)', 'description': 'The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.', 'unitOfMeasure': 'Percent Agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '*1/*1 CYP2C19 Genotype'}, {'id': 'FG001', 'title': '*1/*2 CYP2C19 Genotype'}, {'id': 'FG002', 'title': '*2/*2 CYP2C19 Genotype'}, {'id': 'FG003', 'title': '*1/*3 CYP2C19 Genotype'}, {'id': 'FG004', 'title': '*3/*3 CYP2C19 Genotype'}, {'id': 'FG005', 'title': '*1/*17 CYP2C19 Genotype'}, {'id': 'FG006', 'title': '*17/*17 CYP2C19 Genotype'}, {'id': 'FG007', 'title': '*2/*3 CYP2C19 Genotype'}, {'id': 'FG008', 'title': '*2/*17 CYP2C19 Genotype'}, {'id': 'FG009', 'title': '*3/*17 CYP2C19 Genotype'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '40'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'First Pass', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '39'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '40'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Bidirectional Sequencing not possible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment of study participants was performed without knowledge of participant genotypes by enrolling associates of operators and associates of Spartan Bioscience and Mount Sinai Services.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '325', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': '*1/*1 CYP2C19 Genotype'}, {'id': 'BG001', 'title': '*1/*2 CYP2C19 Genotype'}, {'id': 'BG002', 'title': '*2/*2 CYP2C19 Genotype'}, {'id': 'BG003', 'title': '*1/*3 CYP2C19 Genotype'}, {'id': 'BG004', 'title': '*3/*3 CYP2C19 Genotype'}, {'id': 'BG005', 'title': '*1/*17 CYP2C19 Genotype'}, {'id': 'BG006', 'title': '*17/*17 CYP2C19 Genotype'}, {'id': 'BG007', 'title': '*2/*3 CYP2C19 Genotype'}, {'id': 'BG008', 'title': '*2/*17 CYP2C19 Genotype'}, {'id': 'BG009', 'title': '*3/*17 CYP2C19 Genotype'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '315', 'groupId': 'BG010'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender Not Collected', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '325', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '325', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-28', 'studyFirstSubmitDate': '2012-10-29', 'resultsFirstSubmitDate': '2013-02-07', 'studyFirstSubmitQcDate': '2012-10-30', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-28', 'studyFirstPostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Agreement', 'timeFrame': 'After second pass result is complete (~3hours)', 'description': 'The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cyp2C19', 'Genotyping', 'Spartan', 'Comparison', 'Sequencing'], 'conditions': ['Genotyping Techniques']}, 'descriptionModule': {'briefSummary': "The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 \\*2, \\*3 and \\*17 genotypes from genomic DNA obtained from buccal swab samples. This study is purposed to demonstrate the concordance (positive and negative percent agreement) by comparing the Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the concordance between three different sample transport embodiments provided to laboratories for use in transporting the reagent tubes with collected buccal sample swab to the laboratory.", 'detailedDescription': "The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 \\*2, \\*3 and \\*17 genotypes from genomic DNA obtained from buccal swab samples.\n\nThe FRX system is comprised of hardware and consumable components. The hardware components of the system include an Analyzer (thermal cycler with fluorescence detection capability), a netbook computer and a printer. The consumable component of the FRX system is a sample collection kit. Each kit contains a buccal swab (used to collect the patient sample) and a tube containing the reagents required for genomic DNA extraction and PCR amplification stages of the test.\n\nThe Spartan FRX System is capable of detecting three CYP2C19 SNPs (\\*2, \\*3, \\*17) in each test performed. An individual sample collection kit is required for each SNP tested; therefore three sample collection kits are required for each test performed on the system.\n\nThe FRX System is to be used by trained personnel in CLIA certified laboratories and is for use with buccal samples collected directly from patients. The FRX CYP2C19 test is intended to enable clinicians to identify patients with mutations in the \\*2,\\*3 and \\*17 loci of the CYP2C19 gene and is indicated for use as an aid to clinicians in determining strategies for therapeutics that are metabolized by the CYP2C19 gene product.\n\nTo perform a test, the user collects three buccal samples from the patient and then inserts a sample into each of the three reagent tubes (one for each of the CYP2C19 loci \\*2, \\*3 and \\*17). The reagent tubes are placed into the Analyzer and the FRX system automates the processes of DNA extraction, PCR amplification, fluorescent signal detection and data analysis. The system provides the user with a printed result listing the patient genotypes at the \\*2, \\*3 and \\*17 loci.\n\nThis study has been designed to demonstrate the concordance (positive and negative percent agreement) by comparing the Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the concordance between three different sample transport embodiments provided to laboratories for use in transporting the reagent tubes with collected buccal sample swab to the laboratory.\n\nFor each mutation, agreement of the FRX System against bidirectional sequencing (comparative method) will be calculated: The overall accuracy of the test will be calculated and reported as follows:\n\n* of concordant results between the test and the reference method Accuracy = ----------------------------------------------------------------\n* of samples analyzed by the reference method\n\nThe first and second pass results from the study will be analyzed and tabulated as outlined in the table below. The acceptance criteria for the overall study will be percent in agreement ≥ 99.0% for the second pass with the lower bound of a one-sided 95% confidence interval using the score method ≥ 95.0%."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '320 Individuals with undetermined CYP2C19 \\*2 \\*3 and \\*17 Genotypes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT01718535', 'briefTitle': 'Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spartan Bioscience Inc.'}, 'officialTitle': 'Method Comparison Study of the Spartan FRX CYP2C19 *2, *3, and *17 Genotyping System', 'orgStudyIdInfo': {'id': '01001679'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CYP2C19 Genotyping', 'interventionNames': ['Device: Spartan FRX CYP2C19 Test System']}], 'interventions': [{'name': 'Spartan FRX CYP2C19 Test System', 'type': 'DEVICE', 'armGroupLabels': ['CYP2C19 Genotyping']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1Z5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Services', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Azar Azad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Hospital, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spartan Bioscience Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}