Clinical Trial: Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler

Brief Summary:

This clinical study will demonstrate the accuracy of the chromosomal aberration and gene mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug Administration for in vitro diagnostic use within the United States of America.

The objective is to demonstrate the positive and negative percent agreement of each marker by comparing AMLProfiler results from multiple clinical participating sites with data generated using a laboratory developed bi-directional sequencing method generated at the molecular diagnostic reference lab.

The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or APL specific chromosomal aberrations (specific recurrent translocations and inversions), as well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of patients with Acute Myeloid Leukemia.


Detailed Summary:
Sponsor: Skyline Diagnostics BV

Current Primary Outcome: Acceptance Criteria [ Time Frame: Sample taken at initial visit with no follow up (Day 1) ]

The acceptance criteria based on lower level of the 95% CI of the positive or negative percent agreement for all markers.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Skyline Diagnostics BV

Dates:
Date Received: October 28, 2011
Date Started: October 2011
Date Completion:
Last Updated: May 27, 2013
Last Verified: May 2013