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

Terminated

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

• Registration Number: NCT01463410
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-10-31
• Study First Posted: 2011-11-01
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-27
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 264

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptance Criteria	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.

Trial Locations

Locations (5)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

University Hospital Ulm; 🇩🇪 Ulm, Germany

James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States

Cardiff University; 🇬🇧 Cardiff, Heath Park, United Kingdom