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

Completed

• Conditions: Detection and Genotyping of Factor V and Factor II Point Mutations

• Registration Number: NCT00959504
• Lead Sponsor: Illumina, Inc.

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 available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified