Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA

This study has been completed.

Sponsor:

Information provided by:

Illumina, Inc.

ClinicalTrials.gov Identifier:

NCT00959504

First received: August 13, 2009

Last updated: June 7, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 13, 2009
Last Updated Date	June 7, 2011
Start Date ^ICMJE	August 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00959504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA
Official Title ^ICMJE	VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing.
Condition ^ICMJE	Detection and Genotyping of Factor V and Factor II Point Mutations
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	275
Completion Date	September 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing. Exclusion Criteria: 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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00959504
Other Study ID Numbers ^ICMJE	ILMN001
Has Data Monitoring Committee	Yes
Responsible Party	Don Ellis, Sr. Director of Quality, Illumina
Study Sponsor ^ICMJE	Illumina, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Illumina, Inc.
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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