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

NCT ID: NCT01835483

Last Updated: 2014-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

867 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Factor V Leiden Factor II Thrombosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* suspected thrombophilia
* 18 years of age or older

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sequenom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sequenom Center for Molecular Medicine

Grand Rapids, Michigan, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

The Methodist Hospital Research Institute

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SQNM-FVL-300

Identifier Type: -

Identifier Source: org_study_id

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