Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
Stopped early
Conditions studied: Acute Myeloid Leukemia (AML), Acute Promyelocytic Leukemia (APL), Refractory Anemia With Excess of Blasts (RAEB)
In brief
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.
Key facts
- Study ID
- NCT01463410
- Run by
- Skyline Diagnostics BV
- People needed
- 264
- Starts
- 2011-10-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2013-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects with a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- ≥ 18 years
- Written informed consent
You may not qualify if…
- Subjects without a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- < 18 years
- Without written informed consent
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- James Cancer Hospital — Columbus, Ohio, United States
- University Hospital Ulm — Ulm, Germany
- Erasmus Medical Center — Rotterdam, Netherlands
- Cardiff University — Cardiff, Heath Park, United Kingdom
Full record on ClinicalTrials.gov
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