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Study of Biomarkers in DNA Samples From Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01005277
First received: October 29, 2009
Last updated: October 31, 2009
Last verified: October 2009
History of Changes
  Purpose

RATIONALE: Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia.


Condition Intervention
Leukemia
 Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: polymorphism analysis

Study Type: Observational
Official Title: Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Collection of DNA samples for use in analysis of a wide range of host factors influencing etiology and outcome of disease [ Designated as safety issue: No ]
  • Host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered [ Designated as safety issue: No ]

Study Start Date: April 2002
Detailed Description:

OBJECTIVES:

  • Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease.
  • Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered.

OUTLINE: Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • DNA samples available from patients meeting the following criteria:

    • Infants with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
    • Patients with pre-B ALL, including responders vs non-responders in selected genotypes [hyperdiploid, hypodiploid, t(12;21), t(9;22), t(1;19), and t(4;11)] and responders and non-responders regardless of genotype
    • Pediatric patients with AML registered on POG-9421
    • Adult patients with ALL, including t(8.21), inv(16), t(15;17), complex cytogenetics, and secondary AML
    • Pediatric patients with relapsed ALL enrolled on COG-AALL01P2
    • Pediatric patients enrolled on COG-9900 and other CCG or POG trials

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005277

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Stella M. Davies, MBBS, PhD Children's Hospital Medical Center, Cincinnati
  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

ClinicalTrials.gov Identifier: NCT01005277     History of Changes
Other Study ID Numbers: CDR0000271322, COG-ABTR02B1
Study First Received: October 29, 2009
Last Updated: October 31, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute lymphoblastic leukemia in remission
recurrent childhood acute lymphoblastic leukemia
childhood acute myeloid leukemia in remission
childhood acute myeloid leukemia/other myeloid malignancies
recurrent childhood acute myeloid leukemia
 secondary acute myeloid leukemia
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(8;21)(q22;q22)

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

ClinicalTrials.gov processed this record on May 16, 2013