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

NCT01463410 | Terminated

• 1 other identifier: PROT-015
• Study Type: observational
• Target: 264
• Locations: 4 countries
• Sites: 5

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.

Conditions

Acute Myeloid Leukemia (AML); Acute Promyelocytic Leukemia (APL); Refractory Anemia With Excess of Blasts (RAEB)

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Skyline Diagnostics BV: lead
• Illumina, Inc.: collaborator

Study Sites (5)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

University Hospital Ulm

Ulm, 89081, Germany

Location

Erasmus Medical Center

Rotterdam, 3015 AA, Netherlands

Location

Cardiff University

Cardiff, Heath Park, CF144XN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

RNA from bone marrow samples will be retained.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Promyelocytic, Acute; Anemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 1, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

NL (1); US (2); DE (1); GB (1)