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Gene Expression in Tissue From Patients With Acute Lymphoblastic Leukemia

Genetic Risk Classes in Adult Acute Lymphocytic Leukemia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00898261
Enrollment
137
Registered
2009-05-12
Start date
2007-10-26
Completion date
2012-07-19
Last updated
2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

adult acute lymphoblastic leukemia in remission

Brief summary

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.

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

GENETICmicroarray analysis
GENETICreverse transcriptase-polymerase chain reaction
OTHERflow cytometry

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime 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 phenotype1 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 abnormalities1 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 survival1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026