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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT01284010

First received: January 25, 2011

Last updated: July 1, 2016

Last verified: July 2016

History of Changes

Purpose

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.

Condition	Intervention
Leukemia	Genetic: DNA analysis Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional
Official Title:	Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphosarcoma

U.S. FDA Resources

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:

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 ]


Estimated Enrollment:	200
Study Start Date:	February 2011
Estimated Primary Completion Date:	January 2100 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 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.	Genetic: DNA analysis Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis

Detailed 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.

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Acute lymphoblastic leukemia (ALL) patients treated on protocols CALGB 9511, 19802, 10001, 10102, and 10403, and who have been registered on the companion study CALGB 9665 (The CALGB Leukemia Tissue Bank)

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284010

Locations


United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators


Study Chair:	James Downing, MD	St. Jude Children's Research Hospital

More Information


Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT01284010 History of Changes
Other Study ID Numbers:	CALGB-21001 RC1CA145707 ( U.S. NIH Grant/Contract ) P30CA014236 ( U.S. NIH Grant/Contract ) CDR0000694150 ( Registry Identifier: NCI Physician Data Query )
Study First Received:	January 25, 2011
Last Updated:	July 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology:


adult acute lymphoblastic leukemia

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on July 21, 2017

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