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

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ClinicalTrials.gov Identifier: NCT01463410
Recruitment Status : Terminated (The required number of banked samples could not be met due to limited availability. There is no realistic possibility to complete the study succesfully.)
First Posted : November 1, 2011
Last Update Posted : May 29, 2013
Sponsor:
Collaborator:
Illumina, Inc.
Information provided by (Responsible Party):
Skyline Diagnostics BV

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.


Condition or disease
Acute Myeloid Leukemia (AML) Acute Promyelocytic Leukemia (APL) Refractory Anemia With Excess of Blasts (RAEB)

Study Type : Observational
Actual Enrollment : 264 participants
Observational Model: Case-Only
Official Title: Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
Study Start Date : October 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013





Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
RNA from bone marrow samples will be retained.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463410


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
James Cancer Hospital
Columbus, Ohio, United States, 43210
Germany
University Hospital Ulm
Ulm, Germany, 89081
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3015 AA
United Kingdom
Cardiff University
Cardiff, Heath Park, United Kingdom, CF144XN
Sponsors and Collaborators
Skyline Diagnostics BV
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

Additional Information:
Responsible Party: Skyline Diagnostics BV
ClinicalTrials.gov Identifier: NCT01463410     History of Changes
Other Study ID Numbers: PROT-015
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Anemia, Refractory
Leukemia, Promyelocytic, Acute
Chromosome Aberrations
Chromosome Disorders
Anemia, Refractory, with Excess of Blasts
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Pathologic Processes
Congenital Abnormalities
Genetic Diseases, Inborn