Status:
TERMINATED
Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
Lead Sponsor:
Skyline Diagnostics BV
Collaborating Sponsors:
Illumina, Inc.
Conditions:
Acute Myeloid Leukemia (AML)
Acute Promyelocytic Leukemia (APL)
Eligibility:
All Genders
18+ years
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 suppor...
Eligibility Criteria
Inclusion
- Subjects with a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- ≥ 18 years
- Written informed consent
Exclusion
- Subjects without a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- \< 18 years
- Without written informed consent
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT01463410
Start Date
October 1 2011
End Date
March 1 2013
Last Update
May 29 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
James Cancer Hospital
Columbus, Ohio, United States, 43210
3
University Hospital Ulm
Ulm, Germany, 89081
4
Erasmus Medical Center
Rotterdam, Netherlands, 3015 AA