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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Myeloid Leukemia (AML); Acute Promyelocytic Leukemia (APL); Refractory Anemia With Excess of Blasts (RAEB)

• Study Type: Observational
• Enrollment (Actual): 264

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany, 89081
    • University Hospital Ulm
• Netherlands
  • Rotterdam, Netherlands, 3015 AA
    • Erasmus Medical Center
• United Kingdom
  • Heath Park
    • Cardiff, Heath Park, United Kingdom, CF144XN
      • Cardiff University
• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • James Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Bone marrow samples will be used in the study only from AML,APL or RAEB subjects. Written informed consent by subjects will be obtained for use of their bone marrow samples in this study. Each site will follow their own bone marrow aspiration procedure.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance Criteria	The acceptance criteria based on lower level of the 95% CI of the positive or negative percent agreement for all markers.	Sample taken at initial visit with no follow up (Day 1)

Collaborators and Investigators

• Sponsor: Skyline Diagnostics BV
• Collaborators: Illumina, Inc.
• Investigators: Principal Investigator: Martin Tallman, MD, Memorial Sloan Kettering Cancer Center; Principal Investigator: Guido Marcucci, MD, James Cancer Hospital; Principal Investigator: Alan Burnett, MD, Cardiff University- School of Medicine; Principal Investigator: Hartmut Doehner, MD, University Hospital Ulm; Principal Investigator: Bob Lowenberg, MD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (ESTIMATE): November 1, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 29, 2013
• Last Update Submitted That Met QC Criteria: May 27, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Anemia; Leukemia, Myeloid; Myelodysplastic Syndromes; Leukemia; Leukemia, Myeloid, Acute; Leukemia, Promyelocytic, Acute; Chromosome Aberrations; Anemia, Refractory, with Excess of Blasts; Anemia, Refractory
• Other Study ID Numbers: PROT-015