Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia

May 16, 2016 updated by: Children's Oncology Group

Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL)

RATIONALE: 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.

PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young patients with acute lymphoblastic leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To manage and oversee determination of genome-wide genotypes using common laboratory methodologies for young patients with newly diagnosed acute lymphoblastic leukemia (ALL).
  • To provide a mechanism for storing, distributing, and tracking usage of blast and germline genomic information for approved projects.
  • To facilitate research for childhood ALL using genome-wide germline and blast data to identify genetic variations associated with important phenotypes: treatment response (e.g., relapse risk, minimal residual disease status), adverse effects (e.g., osteonecrosis, infection risk, neurotoxicity), risk of ALL, and risk of ALL subtypes (e.g., TEL/AML1, BCR/ABL, T-cell).
  • To provide a data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL.

OUTLINE: This is a multicenter study.

DNA from previously collected and banked blood and bone marrow samples is utilized for genome-wide genotyping.

Genotype data is only used to examine specific questions related to the epidemiology and etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for development of side effects, and complications related to treatment.

Study Type

Observational

Enrollment (Anticipated)

1000

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

1 year to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Young Patients With Acute Lymphoblastic Leukemia

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL)
  • Previously enrolled in COG-9900, COG-C1991, COG-AALL03B1, COG-AALL05B1, COG-AALL08P1, or other current COG or legacy trials for ALL AND consented to submit blood and marrow samples for biological research studies

  • Meets ≥ 1 of the following criteria:

    • Germline DNA that has been extracted from blood (preferentially) or bone marrow (if no appropriate blood available) that was collected on or after Day 28 of remission indication therapy, or is known to come from a sample that contained < 10% leukemic blasts
    • ALL blast DNA that has been extracted from bone marrow (preferentially) or blood (if from a sample that contained > 90% leukemic blasts and no diagnostic bone marrow is available) that was collected at the time of ALL diagnosis

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

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: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determination of genome-wide genotypes
Mechanism for storing, distributing, and tracking usage of blast and germline genomic information
Identification of genetic variations associated with important phenotypes (treatment response, adverse effects, risk of acute lymphoblastic leukemia [ALL], and risk of ALL subtypes)
Data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL

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)

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

November 1, 2009

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (Estimate)

November 19, 2009

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AALL08B2
  • COG-AALL08B2
  • CDR0000659101
  • NCI-2011-02200 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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