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

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01463410
• Other study ID #: PROT-015
• Status: Terminated
• Phase: N/A
• First received: October 28, 2011
• Last updated: May 27, 2013
• Start date: October 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Skyline Diagnostics BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 264
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Acute Promyelocytic Leukemia (APL)
• Anemia, Refractory, with Excess of Blasts
• Chromosome Aberrations
• Chromosome Disorders
• Leukemia
• Leukemia, Myeloid, Acute
• Leukemia, Promyelocytic, Acute
• Refractory Anemia With Excess of Blasts (RAEB)

Locations

Country	Name	City	State
Germany	University Hospital Ulm	Ulm
Netherlands	Erasmus Medical Center	Rotterdam
United Kingdom	Cardiff University	Cardiff	Heath Park
United States	James Cancer Hospital	Columbus	Ohio
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Skyline Diagnostics BV	Illumina, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No

External Links

•   Myraqa
•   Skyline Diagnostics