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

NCT01463410 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 264

Last updated 2013-05-29

No results posted yet for this study

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)

Sponsors & Collaborators

  • Illumina, Inc.

    collaborator INDUSTRY

  • Skyline Diagnostics BV

    lead INDUSTRY

Principal Investigators

  • Martin Tallman, MD · Memorial Sloan Kettering Cancer Center

  • Guido Marcucci, MD · James Cancer Hospital

  • Alan Burnett, MD · Cardiff University- School of Medicine

  • Hartmut Doehner, MD · University Hospital Ulm

  • Bob Lowenberg, MD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • United States
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463410 on ClinicalTrials.gov