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

May 17, 2016 updated by: Children's Oncology Group

Genetic Predictors of AML Treatment Response

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Diagnosis of AML in remission

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

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
Up to 2 years
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
From study entry date to completion of therapy date provided on the final Reporting Period case reporting form, assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Richard Aplenc, MD, Children's Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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