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

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.

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Key information

Conditions

Factor V Leiden Cardiovascular Diseases Embolism and Thrombosis Factor II Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sequenom Center for Molecular Medicine, Grand Rapids, Michigan, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

suspected thrombophilia
18 years of age or older

Exclusion criteria

none

Treatment and study plan

Primary outcomes

Performance of the MassPLEX Factor II/V Leiden Test

Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Apr 19, 2013
Registry last updated: Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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