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Completed

NCT Number: NCT01024127

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

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.

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Key information

Conditions

Adult Acute Myeloid Leukemia in Remission Childhood Acute Myeloid Leukemia in Remission

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genetic Predictors of AML Treatment Response

Important dates

Study start
2009
Primary completion
2016
First posted
Dec 2, 2009
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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