Skip to main content
OpenTrials
Completed

NCT Number: NCT00898261

Gene Expression in Tissue From Patients With Acute Lymphoblastic Leukemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microarray analysis

Genetic

reverse transcriptase-polymerase chain reaction

Genetic

flow cytometry

Other

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genetic Risk Classes in Adult Acute Lymphocytic Leukemia

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
May 12, 2009
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.