Spots Global Cancer Trial Database for Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
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Trial Identification
Brief Title: Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
Official Title: Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
Study ID: NCT01463410
Interventions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Memorial Sloan Kettering Cancer Center, New York, New York, United States
James Cancer Hospital, Columbus, Ohio, United States
University Hospital Ulm, Ulm, , Germany
Erasmus Medical Center, Rotterdam, , Netherlands
Cardiff University, Cardiff, Heath Park, United Kingdom
Contact Details
Name: Martin Tallman, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Guido Marcucci, MD
Affiliation: James Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Alan Burnett, MD
Affiliation: Cardiff University- School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Hartmut Doehner, MD
Affiliation: University Hospital Ulm
Role: PRINCIPAL_INVESTIGATOR
Name: Bob Lowenberg, MD
Affiliation: Erasmus Medical Center
Role: PRINCIPAL_INVESTIGATOR
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