Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Myeloid Leukemia (AML)
- Sponsor
- Skyline Diagnostics BV
- Enrollment
- 264
- Locations
- 5
- Primary Endpoint
- Acceptance Criteria
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Acceptance Criteria
Time Frame: 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.