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OpenTrials
Completed

NCT Number: NCT01284010

Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DNA analysis

Genetic

fluorescence in situ hybridization

Genetic

gene expression analysis

Genetic

microarray analysis

Genetic

mutation analysis

Genetic

polymerase chain reaction

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. complete remission rate

    Time frame: Up to 7 Years

  2. disease free survival

    Time frame: Up to 7 Years

  3. cumulative incidence of relapse

    Time frame: Up to 7 years

  4. overall survival

    Time frame: Up to 7 years

  5. event-free survival

    Time frame: Up to 7 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2011
Registry last updated
Feb 20, 2020

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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