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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01463410
Other study ID # PROT-015
Secondary ID
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


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
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