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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01835483

Enrollment

867

Registered

2013-04-19

Start date

2013-05-31

Completion date

2013-07-31

Last updated

2014-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Factor II, Factor V Leiden, Thrombosis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* suspected thrombophilia * 18 years of age or older

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results