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Clinical trialNCT01463410TerminatedObservational

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

SponsorSkyline Diagnostics BVEnrollment264Acute Myeloid Leukemia (AML)Acute Promyelocytic Leukemia (APL)Refractory Anemia With Excess of Blasts (RAEB)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Germany
  • University Hospital Ulm

    Ulm, Germany

Netherlands
  • Erasmus Medical Center

    Rotterdam, Netherlands

United Kingdom
  • Cardiff University

    Cardiff, Heath Park, United Kingdom

United States
  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

  • James Cancer Hospital

    Columbus, Ohio, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2011
Primary completion
28 Feb 2013
Completion
31 Mar 2013
Last update posted
29 May 2013
Registered enrollment
264
Registry id
NCT01463410
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.