临床试验/NCT01835483

NCT01835483已完成不适用

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

Sequenom, Inc.3 个研究点分布在 1 个国家目标入组 867 人开始时间: 2013年5月最近更新: 2014年1月20日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Sequenom, Inc.
入组人数: 867
试验地点: 3
主要终点: Performance of the MassPLEX Factor II/V Leiden Test

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Retrospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•suspected thrombophilia
•18 years of age or older

排除标准

未提供

结局指标

主要结局

Performance of the MassPLEX Factor II/V Leiden Test

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方

Sequenom, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (3)

Loading locations...

相似试验

已完成

不适用

Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNADetection and Genotyping of Factor V and Factor II Point Mutations

NCT00959504Illumina, Inc.275

已完成

不适用

Performance Evaluation of the LumiraDx SARS-CoV-2 & FLU A/B and SARS-CoV-2 & RSV Tests for Aid in the Assessment of COVID-19COVID-19Influenza Type BRSV InfectionInfluenza A

NCT05268939LumiraDx UK Limited668

已完成

不适用

Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus AureusStaphylococcus Aureus

NCT00406549Solventum US LLC2,000

已完成

不适用

Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing SitesInfluenza, HumanRespiratory Syncytial Virus Infections

NCT04288921LumiraDx UK Limited525

Unknown

不适用

Pharmacogenomic Biomarker Study for Recombinant Human Activated Protein C Treatment in Severe SepsisSevere SepsisSeptic Shock

NCT01486524Sirius Genomics Inc.3,000