Clinical trial · Observational
Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The required number of banked samples could not be met due to limited availability. There is no realistic possibility to complete the study succesfully.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Acute Promyelocytic Leukemia (APL) | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Refractory Anemia With Excess of Blasts (RAEB) | Myelodysplastic Syndrome with Excess Blasts | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Acceptance Criteria
- timeFrame
- Sample taken at initial visit with no follow up (Day 1)
- description
- The acceptance criteria based on lower level of the 95% CI of the positive or negative percent agreement for all markers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available