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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
  Purpose

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.


Condition
Detection and Genotyping of Factor V and Factor II Point Mutations

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System

Resource links provided by NLM:

Drug Information available for: Thrombin
U.S. FDA Resources

Further study details as provided by Illumina, Inc.:

Enrollment: 275
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Don Ellis, Sr. Director of Quality, Illumina
ClinicalTrials.gov Identifier: NCT00959504     History of Changes
Other Study ID Numbers: ILMN001
Study First Received: August 13, 2009
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013