Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia
Recruitment status was: Not yet recruiting
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and lean more about biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in blood samples from patients with acute myeloid leukemia.
Genetic: mutation analysis
Genetic: protein analysis
Other: laboratory biomarker analysis
Other: liquid chromatography
Other: mass spectrometry
|Official Title:||Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)|
- Absence of serum 2HG in all samples without an IDH mutation [ Designated as safety issue: No ]
- Relationship between 2HG level and survival outcomes [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
- To determine if serum 2-hydroxyglutarate (2HG) is only detected in acute myeloid leukemia (AML) patients with isocitrate dehydrogenase (IDH) mutations.
- To determine if the level of serum 2HG impacts leukemia-free survival (LFS).
- To determine if the level of serum 2HG impacts overall survival (OS).
- To determine if serum 2HG is undetectable at the time of documented clinical remission (CR) in IDH-mutated patients.
OUTLINE: Archived serum samples are analyzed for 2-hydroxyglutarate expression by reverse-phase liquid chromatography coupled to mass spectrometry. Results are then compared with presence or absence of an IDH mutation, patients' clinical outcome, as well as age, sex, white blood cell count at diagnosis, platelet count, bone marrow blast percentage at diagnosis, circulating (serum) percentage at diagnosis, cytogenetic risk group, presence of FLT3, NPMN1, and/or TET2 mutations, specific IDH mutation, and randomization treatment group allocation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385150
|Principal Investigator:||Courtney DiNardo, MD||Abramson Cancer Center of the University of Pennsylvania|