NCT00898261

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2012

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

4.7 years

First QC Date

May 9, 2009

Last Update Submit

May 17, 2017

Conditions

Leukemia

Keywords

adult acute lymphoblastic leukemia in remission

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    1 month

Interventions

microarray analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
flow cytometryOTHER

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients participating in E2993

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia

Interventions

Microarray AnalysisReverse Transcriptase Polymerase Chain ReactionFlow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, Analytical

Study Officials

  • Elisabeth Paietta, PhD

    Our Lady of Mercy Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

October 26, 2007

Primary Completion

July 19, 2012

Study Completion

July 19, 2012

Last Updated

May 19, 2017

Record last verified: 2017-05