Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler

Status:	Completed
Conditions:	Blood Cancer, Anemia, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	5/27/2013
Start Date:	October 2011
End Date:	November 2012

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.

Inclusion Criteria:

1. Subjects with a cytopathologically confirmed diagnosis of AML subjects with
refractory anemia with excess of blasts (RAEB) according to the WHO 2008
classification

2. ≥ 18 years

3. Written informed consent

Exclusion Criteria:

1. Subjects without a cytopathologically confirmed diagnosis of AML subjects with
refractory anemia with excess of blasts (RAEB) according to the WHO 2008
classification

2. < 18 years

3. Without written informed consent

We found this trial at

sites

James Cancer Hospital

Columbus, Ohio 43210

from

Columbus, OH