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

Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler - AMLProfiler accuracy study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57165

Enrollment

Registered

2011-02-04

Start date

2011-04-12

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia (Acute Myeloid Leukemia and Acute Promyelocytic Leukemia)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Newly diagnosed subjects with a cytopathologically confirmed diagnosis of AML, APL, or refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification prior to start of antileukemic treatment 2)Subjects with a cytopathologically confirmed relapse diagnosis of AML, APL, or refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification prior to start of antileukemic treatment 3) subjects >= 18 years 4) Written informed consent available

Exclusion criteria

Exclusion criteria: Subjects who received chemotherapy or hematopoietic stem cell transplantation within 3 months before bone marrow aspiration for PROT-015.

Design outcomes

Primary

Measure	Time frame
The positive and negative percent agreement of the AMLProfiler to the reference result will be calculated for the t(8;21), t(15;17) (APL), inv(16)/t(16;16), NPM1 mutants (A, B or D) and CEBPA double mutants.	—

Countries

Netherlands

Outcome results