Gene Expression in Tissue From Patients With Acute Lymphoblastic Leukemia

May 17, 2017 updated by: ECOG-ACRIN Cancer Research Group

Genetic Risk Classes in Adult Acute Lymphocytic 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples submitted for research from patients participating in E2993

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2007

Primary Completion (Actual)

July 19, 2012

Study Completion (Actual)

July 19, 2012

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000526268
  • ECOG-E2993T1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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