Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
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.
Acute Myeloid Leukemia (AML)
Acute Promyelocytic Leukemia (APL)
Refractory Anemia With Excess of Blasts (RAEB)
|Study Design:||Observational Model: Case-Only|
|Official Title:||Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler|
- Acceptance Criteria [ Time Frame: Sample taken at initial visit with no follow up (Day 1) ] [ Designated as safety issue: No ]The acceptance criteria based on lower level of the 95% CI of the positive or negative percent agreement for all markers.
Biospecimen Retention: Samples With DNA
RNA from bone marrow samples will be retained.
|Study Start Date:||October 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Ohio|
|James Cancer Hospital|
|Columbus, Ohio, United States, 43210|
|University Hospital Ulm|
|Ulm, Germany, 89081|
|Erasmus Medical Center|
|Rotterdam, Netherlands, 3015 AA|
|Cardiff, Heath Park, United Kingdom, CF144XN|
|Principal Investigator:||Martin Tallman, MD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Guido Marcucci, MD||James Cancer Hospital|
|Principal Investigator:||Alan Burnett, MD||Cardiff University- School of Medicine|
|Principal Investigator:||Hartmut Doehner, MD||University Hospital Ulm|
|Principal Investigator:||Bob Lowenberg, MD||Erasmus Medical Center|