LeukemiaNCT01229956
Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Leukemia
- What is being tested?
- DNA methylation analysis, gene expression analysis and microarray analysis
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients With Acute Myeloid Leukemia.
DISEASE CHARACTERISTICS:
- Available cryopreserved cells from diagnosis
- At least 2 x 10^7 viably cryopreserved cells
- One of the following biologically defined cytogenetics/molecular cohorts:
- t(9;11)
- t(11;19)
- Other 11q23 translocations
- Normal cytogenetics
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Promoter Methylation in MLL-Rearranged Childhood AML
RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- To determine whether the pattern of global and TSG-specific promoter CpG island hypermethylation and gene silencing that we have shown characterizes MLL-rearranged (MLL-r) infant bilineage ALL is also characteristic of other subsets of MLL-r leukemia.
OUTLINE: Previously collected cryopreserved cells from diagnosis are analyzed for promoter methylation via HELP arrays, gene expression arrays, and RT-qPCR.
PROJECTED ACCRUAL: A total of 32 samples (8 from each of 4 biologically defined cohorts) will be analyzed.
- Conditions
- Leukemia
- Being tested
- DNA methylation analysis, gene expression analysis, microarray analysis, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis
- Keywords
- childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation analysisGenetic
gene expression analysisGenetic
microarray analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startNov 2010
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patrick N. Brown, MD, Principal investigator, CHRISTUS Santa Rosa Cancer Center at CHRISTUS Santa Rosa Hospital - City Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229956
- Sponsor's protocol ID
- AAML11B3
- Other IDs
- COG-AAML11B3, NCI-2011-02842, AAML11B3
- Status last verified
- May 2016
- First submitted
- 27 Oct 2010
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoter Methylation in MLL-Rearranged Childhood AML
- ClinicalTrials.gov ID
- NCT01229956
- Acronym / sponsor ID
- AAML11B3
- Conditions
- Leukemia
- Keywords
- childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2010
- Primary completion
- May 2016 (actual)
- First posted
- 28 Oct 2010 (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 tissue from patients with cancer the in laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- To determine whether the pattern of global and TSG-specific promoter CpG island hypermethylation and gene silencing that we have shown characterizes MLL-rearranged (MLL-r) infant bilineage ALL is also characteristic of other subsets of MLL-r leukemia.
OUTLINE: Previously collected cryopreserved cells from diagnosis are analyzed for promoter methylation via HELP arrays, gene expression arrays, and RT-qPCR.
PROJECTED ACCRUAL: A total of 32 samples (8 from each of 4 biologically defined cohorts) will be analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients With 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 |
|---|---|---|
| DNA methylation analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| microarray analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls
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 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.
Patrick N. Brown, MD principal investigator
CHRISTUS Santa Rosa Cancer Center at CHRISTUS Santa Rosa Hospital - City Centre
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 19 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?
Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls. 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 2016.