Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia
Genetic Predictors of AML Treatment Response
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
l. Perform a genome-wide scan to test for loci associated with acute myeloid leukemia (AML) relapse and infection risk.
II. Validate positive associations seen in the genome-wide scan with a fine mapping approach.
III. Perform simulated clinical trials using germline genetic variation data to test the feasibility of using genetic data to inform the clinical care of pediatric patients with AML.
OUTLINE:
Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosis of AML
- In remission
- Adequate DNA from peripheral blood or bone marrow samples
- Concurrent enrollment on CCG-2961, COG-AAML03P1, COG-AAML0531, AML-93, AML-97, AML-04,AML-09, or Canada AML Infection clinical trial required
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Ancillary-correlative (predictors of AML treatment outcomes)
Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping.
Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.
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Correlative studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of first acute myeloid leukemia relapse
Time Frame: Up to 2 years
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Up to 2 years
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Rate of invasive bacterial infections defined as the number of invasive infection episodes divided by the days at risk
Time Frame: From study entry date to completion of therapy date provided on the final Reporting Period case reporting form, assessed up to 2 years
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From study entry date to completion of therapy date provided on the final Reporting Period case reporting form, assessed up to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Aplenc, MD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAML10B11 (Other Identifier: CTEP)
- NCI-2011-02202 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000660540 (Other Identifier: Clinical Trials.gov)
- COG-AAML10B11 (Other Identifier: Children's Oncology Group)
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