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Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

This study is not yet open for participant recruitment.
Verified June 2011 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01385150
First received: June 28, 2011
Last updated: July 7, 2011
Last verified: June 2011
History of Changes

June 28, 2011
July 7, 2011
August 2011
September 2011   (final data collection date for primary outcome measure)
Absence of serum 2HG in all samples without an IDH mutation [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01385150 on ClinicalTrials.gov Archive Site
Relationship between 2HG level and survival outcomes [ Designated as safety issue: No ]
Same as current
Not Provided
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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)

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.

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.
Observational
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Leukemia
  • Genetic: mutation analysis
  • Genetic: protein analysis
  • Other: laboratory biomarker analysis
  • Other: liquid chromatography
  • Other: mass spectrometry
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
220
Not Provided
September 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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
Both
17 Years to 60 Years
No
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NCT01385150
CDR0000702952, ECOG-E1900T8
Not Provided
Robert L. Comis, ECOG Group Chair's Office
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Courtney DiNardo, MD Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP