Determination of Performance Characteristics of the MassPLEX Factor II/V Leiden Test

Thrombosis Clinical Trial

Official title:

A Multicenter Clinical Study to Determine the Performance Characteristics of the MassPLEX Factor II and Factor V Leiden Genotyping Test in Patients With Suspected Thrombophilia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835483
• Other study ID #: SQNM-FVL-300
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: January 16, 2014
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: January 2014
• Source: Sequenom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.

Description:

De-identified banked genomic DNA samples derived from whole blood from subjects with suspected thrombophilia will be collected from one or more clinical sites. Three clinical laboratory sites will analyze the samples with the FII/FVL Test. Bi-directional DNA sequencing will be performed on all samples at an independent core reference laboratory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 867
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• suspected thrombophilia

• 18 years of age or older

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Factor II
• Factor V Leiden
• Thrombosis

Locations

Country	Name	City	State
United States	Sequenom Center for Molecular Medicine	Grand Rapids	Michigan
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Sequenom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of the MassPLEX Factor II/V Leiden Test	Overall percent agreement of the FII/FVL Test results to the bi-directional DNA sequencing results.	Samples are collected at time of suspected thrombotic event.	No