Trials / Completed
CompletedNCT01385150
Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia
Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 220 (actual)
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 17 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: Primary * To determine if serum 2-hydroxyglutarate (2HG) is only detected in acute myeloid leukemia (AML) patients with isocitrate dehydrogenase (IDH) mutations. Secondary * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | mutation analysis | |
| GENETIC | protein analysis | |
| OTHER | laboratory biomarker analysis | |
| OTHER | liquid chromatography | |
| OTHER | mass spectrometry |
Timeline
- Start date
- 2012-01-03
- Primary completion
- 2012-02-03
- Completion
- 2012-02-03
- First posted
- 2011-06-29
- Last updated
- 2017-05-19
Source: ClinicalTrials.gov record NCT01385150. Inclusion in this directory is not an endorsement.