LeukemiaNCT01507441
Studying DNA in Samples From Younger Patients With Down Syndrome and Acute Myeloid Leukemia Treated on COG-AAML0431 Clinical Trial
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 3 years
- Conditions the study is for
- Leukemia
- What is being tested?
- gene mapping, microarray analysis and mutation analysis
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to 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 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Down syndrome children diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).
DISEASE CHARACTERISTICS:
- Down syndrome children diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS)
- Clinical samples from patients enrolled on the Children's Oncology Group (COG) AAML0431 phase III clinical trial, and from the Children's Hospital of Michigan Cell Bank
- Diagnostic blast samples and matched remission samples
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Whole Exon Sequencing of Down Syndrome Acute Myeloid 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 DNA samples from patients with Down syndrome and acute myeloid leukemia treated on COG-AAML0431 clinical trial.
Read the detailed description
OBJECTIVES:
- To identify new genetic abnormalities associated with acute myeloid leukemia (AML) in patients with Down syndrome through whole-genome sequencing.
OUTLINE: This is a multicenter study.
Extracted DNA and RNA from cryopreserved specimens are analyzed for genomic sequencing, gene mutation, and microarray analysis.
- Conditions
- Leukemia
- Being tested
- gene mapping, microarray analysis, mutation analysis, nucleic acid sequencing, laboratory biomarker analysis
- Keywords
- childhood myelodysplastic syndromes, childhood acute myeloid leukemia/other myeloid malignancies, childhood acute megakaryocytic leukemia (M7)
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene mappingGenetic
microarray analysisGenetic
mutation analysisGenetic
nucleic acid sequencingGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of unique mutations through whole-genome sequencing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startFeb 2012
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Taub, MD, Principal investigator, Children's Hospital of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507441
- Sponsor's protocol ID
- AAML12B4
- Other IDs
- COG-AAML12B4, AAML12B4, NCI-2012-00108
- Status last verified
- May 2016
- First submitted
- 6 Jan 2012
- 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
- Whole Exon Sequencing of Down Syndrome Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01507441
- Acronym / sponsor ID
- AAML12B4
- Conditions
- Leukemia
- Keywords
- childhood myelodysplastic syndromes, childhood acute myeloid leukemia/other myeloid malignancies, childhood acute megakaryocytic leukemia (M7)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2012
- Primary completion
- May 2016 (actual)
- First posted
- 10 Jan 2012 (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 DNA samples from patients with Down syndrome and acute myeloid leukemia treated on COG-AAML0431 clinical trial.
Detailed description
OBJECTIVES:
- To identify new genetic abnormalities associated with acute myeloid leukemia (AML) in patients with Down syndrome through whole-genome sequencing.
OUTLINE: This is a multicenter study.
Extracted DNA and RNA from cryopreserved specimens are analyzed for genomic sequencing, gene mutation, and microarray analysis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Down syndrome children diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).
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 mapping | Genetic | – |
| microarray analysis | Genetic | – |
| mutation analysis | Genetic | – |
| nucleic acid sequencing | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Identification of unique mutations through whole-genome sequencing
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.
Jeffrey Taub, MD principal investigator
Children's Hospital of Michigan
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?
Identification of unique mutations through whole-genome sequencing. 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.