LeukemiaNCT01385150
Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia
An observational study of Leukemia, run by Eastern Cooperative Oncology Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 60 years
- Conditions the study is for
- Leukemia
- What is being tested?
- mutation analysis, protein analysis and laboratory biomarker analysis
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2012to 3 Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Samples from patients enrolled on E1900 from whom samples were submitted for research
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
About this study
Official title: 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.
Read the 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
- Leukemia
- Being tested
- mutation analysis, protein analysis, laboratory biomarker analysis, liquid chromatography, mass spectrometry
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), untreated adult acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)
- Medical subject headings
- Leukemia, Congenital Abnormalities, Leukemia, Basophilic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutation analysisGenetic
protein analysisGenetic
laboratory biomarker analysisOther
liquid chromatographyOther
mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of serum 2HG in all samples without an IDH mutation
Measured: 1 day
Secondary outcomes (1)
Relationship between 2HG level and survival outcomes
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study start3 Jan 2012
- Primary completion3 Feb 2012
- Study completion3 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Courtney DiNardo, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385150
- Sponsor's protocol ID
- CDR0000702952
- Other IDs
- ECOG-E1900T8
- Status last verified
- May 2017
- First submitted
- 28 Jun 2011
- Last updated
- 19 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT01385150
- Acronym / sponsor ID
- CDR0000702952
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), untreated adult acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jan 2012 (actual)
- Primary completion
- 3 Feb 2012 (actual)
- Study completion
- 3 Feb 2012 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Samples from patients enrolled on E1900 from whom samples were submitted for research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mutation analysis | Genetic | – |
| protein analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| liquid chromatography | Other | – |
| mass spectrometry | Other | – |
Primary outcome
Absence of serum 2HG in all samples without an IDH mutation
Time frame: 1 day
1 secondary outcome
Relationship between 2HG level and survival outcomes
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney DiNardo, MD principal investigator
Abramson Cancer Center at Penn Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Eastern Cooperative Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of serum 2HG in all samples without an IDH mutation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.