Acute Myeloid Leukemia Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

264

Study ID:

NCT01463410

Recruitment Status:

Terminated

Sponsor:

Skyline Diagnostics BV

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There are 5 Locations for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
James Cancer Hospital
Columbus Ohio, 43210, United States
University Hospital Ulm
Ulm , 89081, Germany
Erasmus Medical Center
Rotterdam , 3015 , Netherlands
Cardiff University
Cardiff Heath Park, CF144, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

264

Study ID:

NCT01463410

Recruitment Status:

Terminated

Sponsor:


Skyline Diagnostics BV

How clear is this clinincal trial information?

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