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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005277
First Posted: October 30, 2009
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Collection of DNA samples for use in analysis of a wide range of host factors influencing etiology and outcome of disease
  • Host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered

Estimated Enrollment: 100
Study Start Date: April 2002
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01005277     History of Changes
Other Study ID Numbers: ABTR02B1
COG-ABTR02B1 ( Other Identifier: Children's Oncology Group )
CDR0000271322 ( Other Identifier: Clinical Trials.gov )
NCI-2009-00325 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 29, 2009
First Posted: October 30, 2009
Last Update Posted: October 9, 2017
Last Verified: October 2017

Keywords provided by Children's Oncology Group:
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, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases