Gene Expression in Tissue From Patients With Acute Lymphoblastic Leukemia

Overview

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at gene expression in tissue from patients with acute lymphoblastic leukemia enrolled in clinical trial ECOG-2993.

Full Title of Study: “Genetic Risk Classes in Adult Acute Lymphocytic Leukemia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 19, 2012

Detailed Description

OBJECTIVES: – Identify genes involved in specific biologic processes or molecular functions that contribute to the mechanisms by which the BCR/ABL tyrosine kinase induces a leukemic phenotype using RNA banked from patients with BCR/ABL-positive acute lymphoblastic leukemia (ALL) enrolled on ECOG-2993. – Compare patterns of mRNA expression of BCR/ABL fusion protein in patients with B-lineage ALL vs patients with ALL and no cytogenetic abnormalities enrolled on ECOG-2993. – Determine both shared and differing expression patterns in patients with BCR/ABL-positive and cytogenetically negative ALL with respect to achievement of complete remission and duration of disease-free and overall survival. OUTLINE: This is a multicenter study. Total RNA is isolated from stored tissue samples and integrity is verified by reverse transcription-polymerase chain reaction (RT-PCR). cDNA libraries are created from total RNA and gene expression is analyzed via microarray analysis. Genes of interest are further analyzed by flow cytometry and RT-PCR. PROJECTED ACCRUAL: A total of 137 patients will be accrued for this study.

Interventions

  • Genetic: microarray analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: flow cytometry

Clinical Trial Outcome Measures

Primary Measures

  • Genes involved in specific biologic processes or molecular functions that contribute to the mechanisms by which the BCR/ABL tyrosine kinase induces a leukemic phenotype
    • Time Frame: 1 month
  • Comparison of patterns of mRNA expression of BCR/ABL fusion protein in patients with B-lineage acute lymphoblastic leukemia (ALL) vs patients with ALL who lack cytogenetic abnormalities
    • Time Frame: 1 month
  • Shared and differing expression patterns in patients with BCR/ABL-positive and cytogenetically negative ALL with respect to achievement of complete remission and duration of disease-free and overall survival
    • Time Frame: 1 month

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of acute lymphoblastic leukemia – Tissue banked on protocol ECOG-2993 meeting the following criteria: – Leukemic blast cell population immunophenotyped in detail (e.g., including CD25) in ECOG's Immunophenotyping Reference Laboratory – Flow cytometric analysis of gated blast cells reveals association with the B-cell lineage – Mononuclear cell fraction used for RNA isolation contains 75-99% blasts (median 85%) – Negative for TEL/AML1, MLL/AF4, and E2A/PBX1 by qualitative reverse transcription-polymerase chain reaction (RT-PCR) – No FLT3 gene mutations – BCR/ABL-positive samples meeting the following criteria: – Presence of t(9;22)(q34;q11) by standard cytogenetics – Detection of either p190 BCR/ABL or p210 BCR/ABL transcripts by qualitative RT-PCR – Patients with genetic risk factors must meet the following criterion: – Only a normal diploid karyotype is present in ≥ 15 metaphases by standard cytogenetics PATIENT CHARACTERISTICS: – Not specified PRIOR CONCURRENT THERAPY: – Not specified

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ECOG-ACRIN Cancer Research Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elisabeth Paietta, PhD, Study Chair, Our Lady of Mercy Medical Center

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