Trials / Terminated
TerminatedNCT01463410
Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 264 (actual)
- Sponsor
- Skyline Diagnostics BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Acute Myeloid Leukemia (AML)
- Acute Promyelocytic Leukemia (APL)
- Refractory Anemia With Excess of Blasts (RAEB)
Timeline
- Start date
- 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 across 4 countries: United States, Germany, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT01463410. Inclusion in this directory is not an endorsement.