LeukemiaNCT01500499
Role of Biomarkers in Disease Progression in Samples From Patients With Acute Myeloid Leukemia
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Leukemia
- What is being tested?
- gene expression analysis, gene rearrangement analysis and polymerase chain reaction
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to May 2016
- 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Acute myeloid leukemia.
DISEASE CHARACTERISTICS:
- Cryopreserved acute myeloid leukemia specimens
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: The Role of AF1q in Progression of Leukemia
RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies the role of biomarkers in disease progression in samples from patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- To determine the subcellular localization of the MLL-AF1q fusion protein in leukemia cells.
OUTLINE: Cryopreserved specimens are analyzed for MLL-AF1q fusion protein and AF1 gene expression by mass spectrometry, western blot analysis, semi-quantitative PCR, and qPCR.
- Conditions
- Leukemia
- Being tested
- gene expression analysis, gene rearrangement analysis, polymerase chain reaction, protein analysis, western blotting
- Keywords
- adult acute myeloid leukemia, childhood acute myeloid leukemia/other myeloid malignancies
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
gene rearrangement analysisGenetic
polymerase chain reactionGenetic
protein analysisGenetic
western blottingGenetic
laboratory biomarker analysisOther
mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcellular localization of the MLL-AF1q fusion protein in leukemia cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2016
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.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julie D. Saba, MD, PhD, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500499
- Sponsor's protocol ID
- AAML12B2
- Other IDs
- COG-AAML12B2, AAML12B2, NCI-2012-00099
- Status last verified
- May 2016
- First submitted
- 24 Dec 2011
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of AF1q in Progression of Leukemia
- ClinicalTrials.gov ID
- NCT01500499
- Acronym / sponsor ID
- AAML12B2
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia, childhood acute myeloid leukemia/other myeloid malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2011
- Primary completion
- May 2016 (actual)
- First posted
- 28 Dec 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, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies the role of biomarkers in disease progression in samples from patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- To determine the subcellular localization of the MLL-AF1q fusion protein in leukemia cells.
OUTLINE: Cryopreserved specimens are analyzed for MLL-AF1q fusion protein and AF1 gene expression by mass spectrometry, western blot analysis, semi-quantitative PCR, and qPCR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Acute myeloid leukemia.
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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| gene rearrangement analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| protein analysis | Genetic | – |
| western blotting | Genetic | – |
| laboratory biomarker analysis | Other | – |
| mass spectrometry | Other | – |
Primary outcome
Subcellular localization of the MLL-AF1q fusion protein in leukemia cells
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 18 May 2016.
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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.
Julie D. Saba, MD, PhD principal investigator
UCSF Benioff Children's Hospital Oakland
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Children's 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 18 May 2016. 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?
Subcellular localization of the MLL-AF1q fusion protein in leukemia cells. 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 18 May 2016; AzTrials last refreshed its copy on 26 Oct 2026.