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

Completed

• Conditions: Factor V Leiden; Factor II; Thrombosis

• Registration Number: NCT01835483
• Lead Sponsor: Sequenom, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-19
• Study Start: 2013-05
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 867

Inclusion Criteria

• suspected thrombophilia
• 18 years of age or older

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of the MassPLEX Factor II/V Leiden Test	Samples are collected at time of suspected thrombotic event.	Overall percent agreement of the FII/FVL Test results to the bi-directional DNA sequencing results.

Trial Locations

Locations (3)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Sequenom Center for Molecular Medicine; 🇺🇸 Grand Rapids, Michigan, United States

The Methodist Hospital Research Institute; 🇺🇸 Houston, Texas, United States