Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT01385150|
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : May 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: mutation analysis Genetic: protein analysis Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||220 participants|
|Official Title:||Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||January 3, 2012|
|Actual Primary Completion Date :||February 3, 2012|
|Actual Study Completion Date :||February 3, 2012|
- Absence of serum 2HG in all samples without an IDH mutation [ Time Frame: 1 day ]
- Relationship between 2HG level and survival outcomes [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385150
|Principal Investigator:||Courtney DiNardo, MD||Abramson Cancer Center of the University of Pennsylvania|