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Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01024127
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
This research trial studies deoxyribonucleic acid (DNA) in blood or bone marrow samples from younger patients with acute myeloid leukemia. Studying samples of blood 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. It may also help doctors predict how well patients will respond to treatment.

Condition or disease Intervention/treatment
Adult Acute Myeloid Leukemia in Remission Childhood Acute Myeloid Leukemia in Remission Other: Laboratory Biomarker Analysis

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 : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Genetic Predictors of AML Treatment Response
Study Start Date : December 2009
Actual Primary Completion Date : May 2016


Group/Cohort Intervention/treatment
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.
Other: Laboratory Biomarker Analysis
Correlative studies



Primary Outcome Measures :
  1. Incidence of first acute myeloid leukemia relapse [ Time Frame: Up to 2 years ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
blood and bone marrow


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diagnosis of AML in remission
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024127


Locations
United States, Pennsylvania
Children's Oncology Group
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Richard Aplenc, MD Children's Oncology Group

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01024127     History of Changes
Other Study ID Numbers: AAML10B11
NCI-2011-02202 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000660540 ( Other Identifier: Clinical Trials.gov )
COG-AAML10B11 ( Other Identifier: Children's Oncology Group )
AAML10B11 ( Other Identifier: Children's Oncology Group )
AAML10B11 ( Other Identifier: CTEP )
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms