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.
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Notify MeKey information
Conditions
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
reverse transcriptase-polymerase chain reaction
Geneticflow cytometry
OtherPrimary outcomes
-
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
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.
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