Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-03 @ 5:12 PM
Study NCT ID:
NCT00959504
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2009-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 275}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-07', 'studyFirstSubmitDate': '2009-08-13', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Detection and Genotyping of Factor V and Factor II Point Mutations']}, 'descriptionModule': {'briefSummary': 'As an external validation test of the performance of the VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites. This study will assess genotyping accuracy as compared to bidirectional sequencing and genotyping reproducibility across variables such as user, day, and site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing.\n\nExclusion Criteria:\n\n* There are no applicable exclusion criteria for this test, since the genomic sequence will not vary by ethnicity, gender, age or disease. Inappropriately stored blood samples will be excluded.'}, 'identificationModule': {'nctId': 'NCT00959504', 'briefTitle': 'Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Illumina, Inc.'}, 'officialTitle': 'VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System', 'orgStudyIdInfo': {'id': 'ILMN001'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Illumina, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Don Ellis, Sr. Director of Quality', 'oldOrganization': 'Illumina'}}}}