Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia
NCT ID: NCT01385150
Last Updated: 2017-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
220 participants
OBSERVATIONAL
2012-01-03
2012-02-03
Brief Summary
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PURPOSE: This research study is studying biomarkers in blood samples from patients with acute myeloid leukemia.
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Detailed Description
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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
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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mutation analysis
protein analysis
laboratory biomarker analysis
liquid chromatography
mass spectrometry
Eligibility Criteria
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Inclusion Criteria
* Morphologically confirmed acute myeloid leukemia (AML)
* Newly diagnosed with AML
* Serum samples from patients enrolled on the ECOG-1900 clinical trial between 2002 and 2008
* Patients with or without isocitrate dehydrogenase (IDH) mutations
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Received 2 different doses of standard induction chemotherapy on ECOG-1900
17 Years
60 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Courtney DiNardo, MD
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Other Identifiers
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ECOG-E1900T8
Identifier Type: -
Identifier Source: secondary_id
CDR0000702952
Identifier Type: -
Identifier Source: org_study_id
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