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Trial record 1 of 1 for:    NCT00959504
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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:
ClinicalTrials.gov Identifier:
NCT00959504
First Posted: August 14, 2009
Last Update Posted: June 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Illumina, Inc.
  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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Responsible Party: Don Ellis, Sr. Director of Quality, Illumina
ClinicalTrials.gov Identifier: NCT00959504     History of Changes
Other Study ID Numbers: ILMN001
First Submitted: August 13, 2009
First Posted: August 14, 2009
Last Update Posted: June 9, 2011
Last Verified: June 2011