Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 8:58 AM
Study NCT ID:
NCT01385150
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2011-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Study Overview
Official Title:
Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ECOG-E1900T8 | None | None | View |