Overview

This trial is active, not recruiting.

Condition leukemia
Treatments dna analysis, fluorescence in situ hybridization, gene expression analysis, microarray analysis, mutation analysis, polymerase chain reaction, laboratory biomarker analysis
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date February 2011
End date January 2100
Trial size 200 participants
Trial identifier NCT01284010, CALGB-21001, CDR0000694150, P30CA014236, RC1CA145707

Summary

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
Arm
Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients.
dna analysis
fluorescence in situ hybridization
gene expression analysis
microarray analysis
mutation analysis
polymerase chain reaction
laboratory biomarker analysis

Primary Outcomes

Measure
complete remission rate
time frame: Up to 7 Years
disease free survival
time frame: Up to 7 Years
cumulative incidence of relapse
time frame: Up to 7 years
overall survival
time frame: Up to 7 years
event-free survival
time frame: Up to 7 years

Eligibility Criteria

Male or female participants at least 16 years old.

Inclusion: • Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10001, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)

Additional Information

Official title Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia
Description OBJECTIVES: - To perform high-resolution, genome-wide profiling of DNA copy number alterations and loss-of-heterozygosity in samples from adult patients with acute lymphoblastic leukemia (ALL) obtained at diagnosis. - To perform candidate gene resequencing of diagnostic ALL samples. - To examine correlation of genetic alterations with outcome. - To examine the correlation between microarray multi-gene and multi-exon expression signatures with specific alterations and outcome. - To understand genetic events that contribute to the formation, development, and relapse of adult ALL by integrating the copy number and sequence alterations with the multi-gene signatures, and by comparing these data with data already generated in pediatric ALL. OUTLINE: Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.