Childhood Acute Basophilic LeukemiaNCT01076569
Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia
An observational study of Childhood Acute Basophilic Leukemia and Childhood Acute Eosinophilic Leukemia, run by Children's Oncology Group at 1 site in United States.
Trial summary
This pilot research trial studies biomarkers in bone marrow samples from pediatric patients with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Childhood Acute Basophilic Leukemia, Childhood Acute Eosinophilic Leukemia, Childhood Acute Erythroleukemia (M6)
- What is being tested?
- laboratory biomarker analysis
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Any patient with a diagnosis of acute myeloid leukemia meeting the other criteria.
Who may be able to join
- Diagnosis of acute myeloid leukemia
- High-risk disease
- Treated on COG-AAML03P1 or COG-AAML0531
- Meets the following criteria:
- Initial remission with no known adverse risk factors
- High quantity and quality of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) available
- Highly enriched specimens with >= 50% blast available
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Monrovia, California, 91006-3776
About this study
Official title: Target: Identification for High Risk Childhood AML Based on Genome-Wide Analysis
This pilot research trial studies biomarkers in bone marrow samples from pediatric patients with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).
II. To identify mutations, expression profile, gene copy number, loss of heterozygosity (LOH) status and genomic methylation patterns in order to identify novel changes associated with pediatric AML.
III. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.
IV. To identify genomic alterations contributing to induction failure in childhood AML.
OUTLINE:
Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.
- Conditions
- Childhood Acute Basophilic Leukemia, Childhood Acute Eosinophilic Leukemia, Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Minimally Differentiated Myeloid Leukemia (M0), Childhood Acute Monoblastic Leukemia (M5a)
- Being tested
- laboratory biomarker analysis
- Medical subject headings
- Leukemia, Eosinophilic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (molecular analysis) | Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome SNP genotyping, expression, and methylation profiling. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detailed molecular map of pediatric high-risk acute myeloid leukemia
Measured: Baseline
Mutations in identifying novel changes associated with pediatric AML
Measured: Baseline
Expression profile in identifying novel changes associated with pediatric AML
Measured: Baseline
Gene copy number in identifying novel changes associated with pediatric AML
Measured: Baseline
LOH status in identifying novel changes associated with pediatric AML
Measured: Baseline
Genomic methylation patterns in identifying novel changes associated with pediatric AML
Measured: Baseline
Genomic and transcriptome alterations associated with induction failure
Measured: Baseline
Genomic alterations contributing to induction failure in childhood AML
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Acute Basophilic 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-control
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Soheil Meshinchi, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076569
- Sponsor's protocol ID
- AAML10B14
- Other IDs
- NCI-2011-02212, COG-AAML10B14, AAML10B14, AAML10B14, U10CA098543
- Status last verified
- May 2016
- First submitted
- 25 Feb 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
- Target: Identification for High Risk Childhood AML Based on Genome-Wide Analysis
- ClinicalTrials.gov ID
- NCT01076569
- Acronym / sponsor ID
- AAML10B14
- Conditions
- Childhood Acute Basophilic Leukemia, Childhood Acute Eosinophilic Leukemia, Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Minimally Differentiated Myeloid Leukemia (M0), Childhood Acute Monoblastic Leukemia (M5a)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2010
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 Feb 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.
This pilot research trial studies biomarkers in bone marrow samples from pediatric patients with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES:
- To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).
II. To identify mutations, expression profile, gene copy number, loss of heterozygosity (LOH) status and genomic methylation patterns in order to identify novel changes associated with pediatric AML.
III. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.
IV. To identify genomic alterations contributing to induction failure in childhood AML.
OUTLINE:
Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (molecular analysis) | – | Other: laboratory biomarker analysisBanked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome SNP genotyping, expression, and methylation profiling. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Any patient with a diagnosis of acute myeloid leukemia meeting the other criteria.
Key inclusion criteria (7 listed)
- Diagnosis of acute myeloid leukemia
- Treated on COG-AAML03P1 or COG-AAML0531
- Meets the following criteria:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | Ancillary-Correlative (molecular analysis) |
Primary outcome
Detailed molecular map of pediatric high-risk acute myeloid leukemia
Time frame: Baseline
Mutations in identifying novel changes associated with pediatric AML
Time frame: Baseline
Expression profile in identifying novel changes associated with pediatric AML
Time frame: Baseline
Gene copy number in identifying novel changes associated with pediatric AML
Time frame: Baseline
LOH status in identifying novel changes associated with pediatric AML
Time frame: Baseline
Genomic methylation patterns in identifying novel changes associated with pediatric AML
Time frame: Baseline
Genomic and transcriptome alterations associated with induction failure
Time frame: Baseline
Genomic alterations contributing to induction failure in childhood AML
Time frame: Baseline
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.
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.
Soheil Meshinchi, MD principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Acute Basophilic Leukemia and Childhood Acute Eosinophilic Leukemia, run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Detailed molecular map of pediatric high-risk acute myeloid leukemia (time frame: Baseline). The study lists 8 primary outcomes in all. 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.