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

NCT01463410 — Terminated, 264 participants, Skyline Diagnostics BV

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Registry	NCT01463410
Status	Terminated - The required number of banked samples could not be met due to limited availability. There is no realistic possibility to complete the study succesfully.
Study type	Observational
Enrollment	264 (Actual)
Sponsor	Skyline Diagnostics BV (Industry); collaborators: Illumina, Inc.
Conditions	Acute Myeloid Leukemia (AML), Acute Promyelocytic Leukemia (APL), Refractory Anemia With Excess of Blasts (RAEB)
Dates	start 2011-10-01, primary completion 2013-02-01, completion 2013-03-01, first posted 2011-11-01, last updated 2013-05-29
Locations	5 sites in United States, Germany, Netherlands, United Kingdom

-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.

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+Outcome measures

Primary outcomes

Acceptance Criteria [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (5)

Facility	City	Country
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

+Investigators

Martin Tallman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
Guido Marcucci, MD, Principal investigator, James Cancer Hospital
Alan Burnett, MD, Principal investigator, Cardiff University- School of Medicine
Hartmut Doehner, MD, Principal investigator, University Hospital Ulm
Bob Lowenberg, MD, Principal investigator, Erasmus Medical Center