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
1 other identifier
observational
867
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJanuary 20, 2014
January 1, 2014
2 months
April 10, 2013
January 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Eligibility Criteria
Patients with suspected thrombophilia
You may qualify if:
- suspected thrombophilia
- years of age or older
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
Study Sites (3)
Sequenom Center for Molecular Medicine
Grand Rapids, Michigan, 49503, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
Biospecimen
De-identified banked genomic DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 19, 2013
Study Start
May 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
January 20, 2014
Record last verified: 2014-01