Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia
Target: Identification for High Risk Childhood AML Based on Genome-Wide Analysis
4 other identifiers
observational
250
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 19, 2016
May 1, 2016
6.2 years
February 25, 2010
May 17, 2016
Conditions
Outcome Measures
Primary Outcomes (8)
Detailed molecular map of pediatric high-risk acute myeloid leukemia
Baseline
Mutations in identifying novel changes associated with pediatric AML
Baseline
Expression profile in identifying novel changes associated with pediatric AML
Baseline
Gene copy number in identifying novel changes associated with pediatric AML
Baseline
LOH status in identifying novel changes associated with pediatric AML
Baseline
Genomic methylation patterns in identifying novel changes associated with pediatric AML
Baseline
Genomic and transcriptome alterations associated with induction failure
Baseline
Genomic alterations contributing to induction failure in childhood AML
Baseline
Study Arms (1)
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.
Interventions
Eligibility Criteria
Any patient with a diagnosis of acute myeloid leukemia meeting the other criteria.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Children's Oncology Group
Monrovia, California, 91006-3776, United States
Biospecimen
bone marrow
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soheil Meshinchi, MD
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2010
First Posted
February 26, 2010
Study Start
March 1, 2010
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 19, 2016
Record last verified: 2016-05