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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01016379
First received: November 18, 2009
Last updated: January 6, 2010
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Leukemia
 Genetic: DNA analysis
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Determination of genome-wide genotypes [ Designated as safety issue: No ]
  • Mechanism for storing, distributing, and tracking usage of blast and germline genomic information [ Designated as safety issue: No ]
  • Identification of genetic variations associated with important phenotypes (treatment response, adverse effects, risk of acute lymphoblastic leukemia [ALL], and risk of ALL subtypes) [ Designated as safety issue: No ]
  • Data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL [ Designated as safety issue: No ]

Study Start Date: November 2009
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016379

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Mignon Loh, MD University of California, San Francisco
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01016379     History of Changes
Other Study ID Numbers: CDR0000659101, COG-AALL08B2
Study First Received: November 18, 2009
Last Updated: January 6, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013